0001193125-12-111763.txt : 20120313 0001193125-12-111763.hdr.sgml : 20120313 20120313143906 ACCESSION NUMBER: 0001193125-12-111763 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20111231 FILED AS OF DATE: 20120313 DATE AS OF CHANGE: 20120313 FILER: COMPANY DATA: COMPANY CONFORMED NAME: UNIVERSAL BIOSENSORS INC CENTRAL INDEX KEY: 0001279695 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 980424072 STATE OF INCORPORATION: DE FILING VALUES: FORM TYPE: 10-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-52607 FILM NUMBER: 12686804 BUSINESS ADDRESS: STREET 1: 1 CORPORATE AVENUE STREET 2: ROWVILLE CITY: VICTORIA STATE: C3 ZIP: 3178 BUSINESS PHONE: 613-8542-9000 MAIL ADDRESS: STREET 1: 1 CORPORATE AVENUE STREET 2: ROWVILLE CITY: VICTORIA STATE: C3 ZIP: 3178 10-K 1 d266783d10k.htm FORM 10-K Form 10-K
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UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K

x Annual Report Pursuant To Section 13 or 15(d) of the Securities Exchange Act of 1934

For the fiscal year ended December 31, 2011

OR

¨ Transition Report Pursuant To Section 13 or 15(d) of the Securities Exchange Act of 1934

Commission File Number: 000-52607

Universal Biosensors, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware       98-0424072

(State or other jurisdiction of

incorporation or organization)

     

(I.R.S. Employer

Identification Number)

Universal Biosensors, Inc.

1 Corporate Avenue,

Rowville, 3178, Victoria

Australia

(Address of principal

executive offices)

  

Telephone: +61 3 9213 9000

(Registrant’s telephone number,

including area code)

  

Not Applicable

(Zip Code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

  

Name of each exchange on which registered

None    Not applicable

Securities registered pursuant to Section 12(g) of the Act:

Title of each class

Shares of common stock, par value US$0.0001

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.     Yes  ¨        No  x

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.     Yes  ¨        No   x

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  x        No  ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes  x        No  ¨

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.  ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See definitions of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act:

 

Large accelerated filer  ¨   Accelerated filer  x   Non-accelerated filer  ¨    Smaller reporting company  ¨
  (Do not check if a smaller reporting company)            

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).     Yes  ¨        No  x

The approximate aggregate market value of voting and non-voting common equity held by non-affiliates of the registrant was A$85,662,946 (equivalent to US$91,993,437) as of June 30, 2011.

The number of shares outstanding of each of the registrant’s classes of common stock as of March 6, 2012:

 

Title of Class

  

Number of Shares

Common Stock, US$.0001 par value    159,146,213

Documents incorporated by reference:

Certain information contained in the registrant’s definitive Proxy Statement for the 2011 annual meetings of stockholders, to be filed not later than 120 days after the end of the fiscal year covered by this report, is incorporated by reference into Part III hereof.

Information contained on pages F-2 through F-36 of our Annual Report to Stockholders for the fiscal year ended December 31, 2011 is incorporated by reference in our response to Items 7, 7A, 8 and 9A of Part II.

 

 

 

 

 

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TABLE OF CONTENTS

 

         Page  

FORWARD-LOOKING STATEMENTS

     3   

PART I

  

ITEM 1.

  BUSINESS      4   

ITEM 1A.

  RISK FACTORS      10   

ITEM 1B.

  UNRESOLVED STAFF COMMENTS      18   

ITEM 2.

  PROPERTIES      19   

ITEM 3.

  LEGAL PROCEEDINGS      19   

ITEM 4.

  MINE SAFETY DISCLOSURES      19   

PART II

  

ITEM 5.

  MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES      19   

ITEM 6.

  SELECTED FINANCIAL DATA      24   

ITEM 7.

  MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION      25   

ITEM 7A.

  QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK      25   

ITEM 8.

  FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA      26   

ITEM 9.

  CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE      28   

ITEM 9A.

  CONTROLS AND PROCEDURES      28   

ITEM 9B.

  OTHER INFORMATION      31   

PART III

  

ITEM 10.

  DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE      31   

ITEM 11.

  EXECUTIVE COMPENSATION      31   

ITEM 12.

  SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS      31   

ITEM 13.

  CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE      31   

ITEM 14.

  PRINCIPAL ACCOUNTING FEES AND SERVICES      32   

PART IV

  

ITEM 15.

  EXHIBITS, FINANCIAL STATEMENT SCHEDULES      32   

SIGNATURES

       37   

Unless otherwise noted, references on this Form 10-K to “Universal Biosensors” the “Company,” “Group,” “we,” “our” or “us” means Universal Biosensors, Inc. a Delaware corporation and, when applicable, its wholly owned Australian operating subsidiary, Universal Biosensors Pty Ltd. Our principal place of business is located at 1 Corporate Avenue, Rowville, Victoria 3178, Australia. Our telephone number is +61 3 9213 9000. Unless otherwise noted, all references in this Form 10-K to “$”, “A$” or “dollars” and dollar amounts are references to Australian dollars. References to “US$” are references to United States dollars.

 

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FORWARD-LOOKING STATEMENTS

This Form 10-K contains forward-looking statements that involve known and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. All statements, other than statements of historical facts, are forward-looking statements. Forward-looking statements include, but are not limited to, statements about:

 

  Ÿ  

our business and product development strategies;

 

  Ÿ  

our expectations with respect to corporate collaborations or strategic alliances;

 

  Ÿ  

our expectations with respect to the timing and amounts of revenues from our customers and partners;

 

  Ÿ  

our expectations with respect to the services we provide to and, the development projects we undertake for, our customers and partners;

 

  Ÿ  

our expectations with respect to regulatory submissions, approvals, market launches of products we develop or are involved in developing;

 

  Ÿ  

our expectations with respect to sales of products we develop or are involved in developing and the quantities of such products to be manufactured by us;

 

  Ÿ  

our expectations with respect to our research and development programs, the timing of product development and our associated research and development expenses;

 

  Ÿ  

the ability to protect our owned or licensed intellectual property; and

 

  Ÿ  

our estimates regarding our capital requirements, the sufficiency of our cash resources and our need for additional financing.

The words “anticipates,” believes,” “continue,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “projects,” “should,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this Form 10-K. The forward-looking statements included in this Form 10-K do not guarantee our future performance, and actual results could differ from those contemplated by these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. We undertake no obligation to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in cautionary statements throughout this Form 10-K, particularly those set forth in section “Item 1A — Risk Factors.” However, new factors emerge from time to time and it is not possible for us to predict which factors will arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. We do not undertake to update or revise any forward-looking statements.

 

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PART I

ITEM 1.     BUSINESS.

The following discussion and analysis should be read in conjunction with our financial statements and related notes included elsewhere in this Form 10-K. This discussion and analysis contain forward-looking statements based upon current expectations that involve risks and uncertainties. Our actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors, including those set forth in the section entitled “Item 1A — Risk Factors” and elsewhere in this Form 10-K.

Business overview

We are a specialist medical diagnostics company focused on the research, development and manufacture of in vitro diagnostic test devices for consumer and professional point-of-care use.

We were incorporated in the State of Delaware on September 14, 2001 and our shares of common stock in the form of CHESS Depositary Interests (“CDIs”) have been quoted on the Australian Securities Exchange (“ASX”) since December 13, 2006. Our securities are not currently traded on any other public market. Our wholly owned subsidiary and primary operating vehicle, Universal Biosensors Pty Ltd (“UBS”) was incorporated as a proprietary limited company in Australia on September 21, 2001. UBS conducts our research, development and manufacturing activities in Melbourne, Australia.

Our principal place of business is 1 Corporate Avenue, Rowville, Victoria 3178, Australia. Our principal telephone number in Australia is +61 3 9213 9000. Our agent for service in the United States is Corporation Service Company of 2711 Centerville Road, Suite 400, Wilmington, County of New Castle, Delaware, United States. We also maintain a web site at www.universalbiosensors.com. The information contained in, or that can be accessed through, our web site is not part of this Form 10-K.

We have rights to an extensive patent portfolio, with certain patents owned by UBS and a number licensed to UBS under a license agreement between LifeScan, Inc. (“LifeScan”) and UBS (“License Agreement”). LifeScan has granted us a worldwide, royalty free, exclusive license, with a right to sub-license certain electrochemical cell technologies in all fields of use excluding the field of diabetes and blood glucose management generally, the rights to which are retained by LifeScan pursuant to the License Agreement. Unless otherwise noted, references to “LifeScan” in this document are references collectively or individually to LifeScan, Inc., and/or LifeScan Europe, a division of Cilag GmbH International, both affiliates of Johnson and Johnson.

We are using our electrochemical cell technology platform to develop tests for a number of different markets. Our current focus is as set out below:

 

  Ÿ  

Blood glucose — UBS provides services and acts as a non-exclusive manufacturer of test strips for LifeScan’s “OneTouch® VerioTM”, pursuant to a Master Services and Supply Agreement with LifeScan (“Master Services and Supply Agreement”). LifeScan continues its global rollout of the OneTouch Verio product which is currently available in North America, major European markets and Australia. We also undertake research and development work for LifeScan pursuant to a development and research agreement (“Development and Research Agreement”).

 

  Ÿ  

Coagulation testing market — UBS is working with Siemens Healthcare Diagnostics, Inc. (“Siemens”) to develop a range of test strips and reader products for the point-of-care coagulation market, pursuant to a collaboration agreement (“Collaboration Agreement”).

 

  Ÿ  

Other electrochemical-cell based tests — we are working on proving the broader applicability of our technology platform for other immunoassay and molecular diagnostic point-of-care tests. We will seek to enter into collaborative arrangements or strategic alliances with respect to any tests arising from this work.

 

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Our Strategy

We are a specialist medical diagnostics company focused on the research, development and manufacture of in vitro diagnostic test devices for consumer and professional point-of-care use. Key aspects of our strategy include:

 

  Ÿ  

extending our electrochemical cell technology and proving the broader applicability of our technology platform for markets with significant commercial potential;

 

  Ÿ  

seeking to enter into collaborative arrangements or strategic alliances with other life sciences companies or other industry participants to complete the development and commercialization of specific tests or in specific fields;

 

  Ÿ  

undertaking research and development work for our customers and partners;

 

  Ÿ  

manufacturing test strips for our customers and partners as required;

 

  Ÿ  

providing post market support services to our customers and partners.

Plan of Operations for the Remainder of the Fiscal Year Ending December 2012

Our plan of operations over the remainder of the fiscal year ending December 2012 is to:

 

  Ÿ  

continue to undertake research and development work for our customers and partners;

 

  Ÿ  

manufacture test strips to satisfy our customers and partners demand requirements;

 

  Ÿ  

provide the necessary post-market support for our customers and partners;

 

  Ÿ  

prove the broader applicability of our technology platform for markets with significant commercial potential, focusing initially on immunoassay and molecular diagnostic point-of-care tests;

 

  Ÿ  

seek to enter into collaborative arrangements or strategic alliances with other life sciences companies or other industry participants to complete the development and commercialization of specific tests or in specific fields.

Financial information about segments

We operate in one segment. Our principal activities are the research, development and manufacture of in vitro diagnostic test devices for consumer and professional point-of-care use. Although our products are intended for sale worldwide, we operate predominantly in one geographical area, that being Australia. For details of our revenues, profit and loss and total assets for financial years ending December 31, 2011, 2010, 2009, 2008 and 2007 refer to “Item 6. Selected Financial Data”.

Description of our business

We are a specialist medical diagnostics company focused on the research, development and manufacture of in vitro diagnostic test devices for consumer and professional point-of-care use.

Industry background

We operate in the high growth, point-of-care segment of the global in vitro diagnostics (IVD) industry. A large proportion of biological testing has historically been performed by trained scientists at dedicated or centralized testing sites including hospital laboratories and commercial pathology laboratories. Significant interest has developed in techniques and technologies that allow testing to be performed proximate (in time and location) to the patient. Point-of-care testing can be segmented into consumer testing or testing of patients by one of a variety of medical or laboratory professionals in locations such as clinics, physician’s office laboratories and emergency departments. While not all tests are suited to being performed at the point-of-care, we believe our electrochemical cell technology could be a suitable platform for adapting a number of relevant central laboratory tests to a point-of-care format.

 

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Point-of-care tests in development and partnering strategy

Our strategy is to apply the electrochemical cell technology to different fields and biomarkers and then to enter into collaborative arrangements or strategic alliances with third parties to complete the development and commercialization of the products for those fields. We have developed a blood glucose test with LifeScan and are working with Siemens to develop a range of test strip and reader products for the point-of-care coagulation market. We are also working to prove the broader applicability of our technology platform for markets with significant commercial potential, focusing initially on immunoassay and molecular diagnostic point-of-care tests.

Facilities

Universal Biosensors Pty Ltd leases approximately 5,000 square meters of office, research and development and manufacturing facilities at 1 Corporate Avenue, Rowville in Melbourne, Australia. We have had ISO 13485 certification continuously at that site since May 2007. The lease for 1 Corporate Avenue expires on March 31, 2014 with two options to renew the lease for successive five year periods.

Raw materials

Raw materials essential to our business are purchased worldwide in the ordinary course of business from numerous suppliers. In general, these materials are available from multiple sources. Certain of our products in development may be more reliant on sole sources of supply. We will seek to enter into long term contracts of supply with respect to these materials and will develop mitigation strategies, which may include development work to enable substitute materials to be used.

Distribution

We do not currently intend to be responsible for the distribution and marketing of any product we develop. Our strategy is for our partners to be responsible for the commercialization and distribution of the applicable products.

Regulatory clearances

In all major territories of the world, regulatory clearances are required prior to marketing diagnostic tests. The regulatory clearance requirements vary from country to country and product to product, however, regulatory clearances typically require a satisfactory “technical file”, which provides the regulatory bodies with details of the design and previous testing of the product including safety and efficacy data as well as the details of the conduct of trials which show the suitability for use of the product at the point-of-care. Regulators also require demonstration of continuing compliance with an appropriate quality management system. There is no common international regulatory body and we, or our customer or partner, would be required to submit for clearance to sell in each of the major jurisdictions in which the relevant customers and partners seeks to market our products. For example, for Europe, a “Notified Body” assesses the quality system and product technical file, whereas in the United States, the Food and Drug Administration, or “FDA”, is the regulatory body responsible for the examination of the design and performance of the device and for assessment of our quality system.

In the case of point-of-care tests, there are often additional requirements that a manufacturer must meet such as an examination of certain aspects affecting test suitability for non-professional users. In Europe, certain codified standards describe the requirements of tests whilst in the United States, tests to be used by non-laboratory professionals must gain waiver status under the United States Clinical Laboratory Improvement Amendments of 1988. Amongst other clearances, we will also require clearance for export of medical devices from the Therapeutics Goods Administration, or “TGA”, in Australia.

Our customers and partners are generally responsible for obtaining and maintaining all applicable regulatory approvals and determining the location and timing for submissions for regulatory clearance. We may provide a supporting role in this process.

The importance and duration of all our patents, trademarks and licenses

We rely on a combination of patent, copyright, trademark and trade secret laws, as well as confidentiality agreements, to establish and protect our proprietary rights which in the aggregate we believe to be of material importance to us in the operation of our business. Our continued success depends to a large extent on our ability to protect and maintain our owned and licensed patents and patent applications, copyright, trademark and trade secrets.

 

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Our point-of-care tests in development draw upon an extensive portfolio of patents and patent applications as well as know-how either owned by UBS or licensed to UBS by LifeScan. We patent the technology, inventions and improvements that we consider important to the development of our business.

We rely on the owned patent applications and the patents and patent applications licensed to us by LifeScan in the manufacture of the point-of-care diagnostic tests being developed by us and to enable us to grant rights to our customers and partners to commercialize products that we may develop.

Our owned and licensed patents extend for varying periods according to the date of patent filing or grant and the legal term of patents in the various countries where patent protection is obtained. The actual protection afforded by a patent, which can vary from country to country, depends upon the type of patent, the scope of its coverage and the availability of legal remedies in the country. Based on current product sales and our projects, the owned and licensed patents and patent applications that we consider most significant in relation to our business together with the last of the patents to expire within the patent family are set forth in the table below.

 

Patent

   Expiration
Year

Apparatus and Method for Electrochemical Protease Sensor (this patent family relates to a sensor to detect cleavage of an electrochemical substrate for use in measuring blood or plasma coagulation in assays such as prothrombin time and thrombin potential)

   Refer Note 1

Electrochemical On-Board Control Detection (this patent family relates to an on-board control system of a sensor, wherein the control system can test/verify the viability of the sensor)

   Refer Note 1

Electrochemical Cell (this patent family relates to a method and an electrochemical biosensor for determining the concentration of an analyte in a carrier)

   2022

Electrochemical Method (this patent family provides an improved method and biosensor for determination of the concentration of an analyte in a carrier which provides improved accuracy, reliability and speed over prior techniques)

   2024

Electrochemical Cell (this patent family relates to an electrochemical cell for determining the concentration of an analyte in a carrier)

   2016

Electrochemical Method for Measuring Chemical Reaction Rates (this patent family relates to the measurement of the progress of a chemical reaction that generates an electroactive reaction product that is subsequently detected at an electrode amperometrically or coulometrically)

   2023

Electrochemical Cell Connector (this patent family relates to a connector to provide electrical connection between an electrochemical cell of a strip type sensor and meter circuitry)

   2026

Method and Apparatus for Rapid Electrochemical Analysis (this patent application relates to an improved method and apparatus for electrochemical analysis)

   Refer Note 1

Methods and Apparatus for Analyzing a Sample in the Presence of Interferents (this patent application relates to methods and apparatus for determining analyte concentrations in a rapid and accurate manner)

   Refer Note 1

Systems and Methods for Discriminating Control Solution from a Physiological Sample (this patent application relates to systems and methods for discriminating between a control solution and blood sample)

   Refer Note 1

Systems and Methods of Discriminating Control Solution from a Physiological Sample (this patent application relates to systems and methods for discriminating between a control solution and a blood sample based on a summation of current values and comparing reference values to threshold values)

   Refer Note 1

 

1. The patent application is either pending, allowed, or published

We will continue to file and prosecute patent applications when and where appropriate to attempt to protect our rights in our proprietary technologies.

Pursuant to our License Agreement with LifeScan, LifeScan is responsible for prosecution and maintenance of the patents and patent applications licensed to us by them. In the event that LifeScan elects not to proceed with the prosecution of a patent application licensed to us by them or discontinues the payment of fees, we have the right to assume and continue at our own expense the prosecution of any patent or patent applications.

Our ability to build and maintain our proprietary position for our technology and products will depend on our success in obtaining effective claims and those claims being enforced once granted and, with respect to

 

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intellectual property licensed from LifeScan, LifeScan’s success in obtaining effective claims and those claims being enforced once granted. The patent positions of companies like ours are generally uncertain and involve complex legal and factual questions for which important legal principles remain unresolved. Some countries in which we or our customers or partners may seek approval to sell point-of-care tests that we have been involved in developing, may fail to protect our owned and licensed intellectual property rights to the same extent as the protection that may be afforded in the United States or Australia. Some legal principles remain unresolved and there has not been a consistent policy regarding the breadth or interpretation of claims allowed in patents in the United States, the United Kingdom, the European Union, Australia or elsewhere. In addition, the specific content of patents and patent applications that are necessary to support and interpret patent claims is highly uncertain due to the complex nature of the relevant legal, scientific and factual issues. Changes in either patent laws or in interpretations of patent laws in the United States, the United Kingdom, the European Union, Australia or elsewhere may diminish the value of our intellectual property or narrow the scope of our patent protection.

Seasonality

We do not expect sales of the diagnostic tests we develop to be materially impacted by seasonality.

The practices of the registrant and the industry (respective industries) relating to working capital items.

We commenced manufacture in our facility in Corporate Avenue, Rowville, Melbourne, in December 2009. We deal with our inventory and the supply of products in accordance with our contractual obligations to our customers and partners.

Dependence on single customer.

As shown in the table below, we currently receive a significant portion of our revenue from LifeScan.

 

     Years Ended December 31,  
     2011     2010     2009  
     A$     A$     A$  

Revenue from products

     12,063,582        11,760,009        132,733   

Revenue from services

     2,632,870        6,420,027        2,850,071   

Research and development income

                   1,337,125   

Milestone payment

                   17,722,641   

Interest income

     683,323        1,192,889        809,459   

Fee income

                     
  

 

 

   

 

 

   

 

 

 

Total income

     15,379,775        19,372,925        22,852,029   
  

 

 

   

 

 

   

 

 

 

Revenue from LifeScan as a % of total income

     96     94     96

Our dependence on LifeScan for a significant proportion of our revenue is likely to continue until we start to receive meaningful revenues from other collaborative arrangements or strategic alliances with third parties.

Competitive conditions of our business

Our revenue is currently highly dependent on the success of the One-Touch Verio® blood glucose product we have developed with LifeScan. One-Touch Verio® was first launched in the Netherlands in January 2010 and has subsequently been launched in Australia, major European markets and North America. LifeScan is responsible for all sales and marketing decisions and any decision to introduce the product to new territories and the timing of those decisions.

The global diabetes market place is intensely competitive and dominated by multinationals such as LifeScan, Roche, Abbott and Bayer. Although One-Touch Verio® has been well received in the jurisdictions in which it has been launched, we do not yet know if the product will be successful, the extent to which LifeScan will promote One-Touch Verio® when compared to its existing diabetes products, whether customers will prefer

 

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it over competitive offerings, nor the rate at which it might be adopted. During 2012 we will continue to manufacture blood glucose test strips for LifeScan as a non-exclusive manufacturer under the Master Services and Supply Agreement. We anticipate that in the future LifeScan will manufacture all or a large proportion of its own requirements of any blood glucose test strip. If we are unable to compete effectively with LifeScan’s own manufacturing capacity, we may not be able to win a manufacturing commitment from LifeScan and therefore be faced with surplus capacity in our manufacturing operations.

Our research and development expenditure during the last three fiscal years were as follows:

 

     Years Ended December 31,  
     2011      2010      2009  
     A$      A$      A$  

Research and development expenses

     9,812,396         6,482,150         14,898,072   
  

 

 

    

 

 

    

 

 

 

We expect that the range of test strip and reader products for the point-of-care coagulation market that we are developing with Siemens will compete with existing point-of-care technologies from competitors such as Roche Diagnostics, Alere Inc. and Abbott Point of Care. The test will also have to compete with the central laboratory which includes systems marketed by Siemens AG, Diagnostica Stago, Abbott Laboratories and Beckman Coulter, Inc. All of these companies have well established brand recognition, sales and marketing forces, and have significant resources available to support their product.

Core to our business strategy is to extend our intellectual property platform to enable other tests currently done in the central laboratory to be migrated to the point-of-care settings. Our belief is that much testing done in the central lab can more efficiently and profitably be performed at the point-of-care. With the exception of blood glucose testing, most point-of-care testing is currently conducted in professional settings. The health care professional has a choice and can request tests from a central laboratory, or services provider, or choose to have the test performed at the point-of-care. Thus we face competition not just from other companies active in the point-of-care space, but also the providers of testing who operate in centralized settings.

Employees

At March 6, 2012, we had 111 full time employees in our Melbourne facility, spanning production, engineering, quality and regulatory, research and development and administration.

Financial information about geographic areas

We operate in one segment. Our principal activities are research and development, commercial manufacture of approved medical or testing devices and the provision of services including contract research work. We operate predominantly in one geographical area, being Australia.

Available Information

We file annual and quarterly reports, proxy statements and other information with the SEC. Stockholders may read and copy any reports, statements or other information that we file at the SEC’s public reference rooms in Washington, D.C., New York, New York, and Chicago, Illinois. Please call the SEC at 1-800-SEC-0330 for further information about the public reference rooms. Our public filings are also available from commercial document retrieval services and at the Internet Web site maintained by us at http://universalbiosensors.com and the SEC at http://www.sec.gov.

We provide without charge to each person solicited by the Proxy Statement a copy of our Annual Report on Form 10-K, including our financial statements but excluding the exhibits to Form 10-K other than Exhibit 13. The Annual Report includes a list of the exhibits that were filed with the Form 10-K, and we will furnish a copy of any such exhibit to any person who requests it upon the payment of our reasonable expenses in providing the requested exhibit. For further information, please contact our Company Secretary, Cameron Billingsley at +612 8115 9801 or write us at 1 Corporate Avenue, Rowville VIC 3178. You may also send an email to us at companysecretary@universalbiosensors.com. Our Annual Report on Form 10-K and our other filings with the SEC, including the exhibits, are also available for free on our Internet site (http://universalbiosensors.com) and the SEC’s Internet site (http://www.sec.gov).

 

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ITEMS 1A.     RISK FACTORS.

Investing in our shares or CDIs involves a high degree of risk. Before you invest in our shares or CDIs, you should understand the high degree of risk involved. You should carefully consider the following risks and other information in this Form 10-K, including our financial statements and related notes appearing elsewhere in this Form 10-K, before you decide to invest in our shares or CDIs. If any of the events described below actually occurs, our business, financial condition and operating results could be harmed. In such an event, the market price of our CDIs would likely decline and you could lose part or all of your investment.

Our products may not be successful in the marketplace.

Success of products that we are involved in developing is ultimately dependent on the level of market acceptance and sales of those products. Market acceptance will depend on, amongst other things, the ability to provide and maintain evidence of safety, efficacy and cost effectiveness of the products, the advantages and profile over competing products, the level of support from clinicians, the relative convenience and ease of use, cost-effectiveness compared to other products, the availability of reimbursement from national health authorities, the timing of market introduction and the success of marketing and sales efforts by our customers and partners. Additionally, it is difficult to determine the market opportunity for new technologies and our estimates may not accurately reflect the actual demand in the target markets.

Our commercial opportunity will be reduced or eliminated if the size of the market opportunity is less than we expect or if our competitors develop and commercialize products that are safer, more effective, more convenient, less expensive, or reach markets sooner or are marketed better than products that we are involved in developing.

The blood glucose test strips for the One Touch Verio® product was first launched in January 2010. While initial market acceptance for One Touch Verio® has been positive, there is no guarantee that the product will receive a positive acceptance in all countries in which the product will be launched, including in the key jurisdiction of the United States, or that market acceptance will be maintained or will secure adequate market share.

Further, we cannot be sure that any future products we are involved in developing with our customers and partners, such as the test strip and reader products for the point-of-care coagulation market that we are developing with Siemens, will be successful in the marketplace or will secure adequate market share.

Our ability to be or maintain profitability in the future will be adversely affected if any of the products that we are involved in developing fail to achieve or maintain market acceptance or compete effectively in the market place. It would reduce or eliminate our revenues from product sales and manufacturing and have a material adverse effect on our business and financial position.

We are currently dependent on LifeScan for our income.

We are at an early stage of our development as a specialist medical devices company. The vast majority of our income is currently derived from LifeScan and our business is therefore dependent on the level of services we provide to LifeScan, the number of test strips we manufacture for LifeScan and the sales of the blood glucose test strips for the One Touch Verio® product. Any changes in LifeScan’s requirements and the level of test strip sales will directly affect our business.

To date, we have funded our operations primarily through the issue of shares, from payments received from LifeScan, including revenue from products and services and research and development income, and from Australian state and federal grants received by UBS. We do not currently have, and may never have, any products or services that generate substantial revenues.

We act as a non-exclusive manufacturer of the blood glucose test strips we developed with LifeScan. In the future we expect that LifeScan will manufacture all or a large proportion of its own requirements. If our manufacturing capacity is not fully utilized or not utilized at all, we will be faced with surplus capacity in our manufacturing operations and our revenues will decline. If the Master Services and Supply Agreement with LifeScan was terminated as a result of either party defaulting on its material obligations, becoming insolvent, or

 

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as a result of other factors detailed in the Master Services and Supply Agreement we would cease to have the potential to receive service fee revenues from the sale of blood glucose strips. In addition, LifeScan has the ability to terminate the obligation to pay service fees to us by paying us a lump sum amount, but may only do so once it has paid us a certain level of service fees (we do not expect this level of service fees will be achieved until worldwide sales volumes have increased significantly) or as a result of other factors detailed in the Master Services and Supply Agreement. The service fee revenue is an ongoing amount LifeScan is obligated to pay to us based on the number of strips sold by LifeScan regardless of who manufactures the strips. If LifeScan was able to and did terminate the service fees, although we would receive a large lump sum payment, we would cease to receive ongoing service fee revenue and our ongoing future business would be adversely affected.

Our customers and partners may choose to utilize less of our research and development services. If the development and research work we undertake was materially reduced or ceased, we would lose an ongoing source of income which would have a material adverse effect on our business and financial position.

Our business strategy and revenue relies on our ability to enter collaborative arrangements with other companies and there is a risk that we will not be able to enter into collaborative arrangements or strategic alliances with respect to our products.

Our business strategy involves proving the broader applicability of our technology platform for a number of different products/technologies and then entering into collaborative arrangements, licensing agreements or strategic alliances with other life sciences companies or other industry participants for these products/ technologies. We have not established any internal product sales and marketing capacity and to achieve commercial success we must enter into and maintain successful arrangements with others to sell, market and distribute products that we are involved in developing. In seeking a collaborative arrangement, we need to compete against hundreds of technology companies for the attention of the limited pool of global multinationals. We may not be able to enter into such collaborative arrangements or strategic alliances in a timely fashion and on acceptable terms, if at all. An inability to enter such arrangement would be detrimental to our strategy, business and financial position.

Our ability to enter into collaborative arrangements or strategic alliances will suffer if the performances of the technologies developed by us are not perceived as being comparable or superior to established laboratory methods or other products. Other competitive factors may also act as obstacles in our ability to enter into partnership arrangements for certain opportunities.

If we are unable to enter collaborative arrangements with respect to certain of our products/technologies, we may have to delay, reduce the scope of or eliminate some or all of our development programs or liquidate some or all of our assets or seek to raise additional capital. As a result, we may not be able to pursue what we consider to be worthwhile commercial opportunities and significant monies and management time invested may be rendered unproductive and worthless. An inability to enter a collaborative arrangement or partnership would thus have a material adverse effect on our business and financial position.

Entering collaborative arrangements with respect to our products will expose us to risks and uncertainties related to those collaborations and alliances.

To the extent we are able to enter into collaborative arrangements or strategic alliances with respect to our products, we will be exposed to risks and uncertainties related to those collaborations and alliances. The customer or partner will generally makes the key decisions on product choice, regulatory approvals, product launch, product manufacture and marketing and promotion. Decisions made by our partner with respect to the commercialization of the products we develop with them will significantly affect the extent and timing of revenues to us. For example, our partner may choose not to launch new products we develop, may choose to launch the products in a limited number of jurisdictions, may delay the launch of products, may undertake only limited sales and marketing efforts to commercialize the products, all of which would have a material adverse effect on our business and financial position. Collaborative arrangements, licensing agreements or strategic alliances will subject us to a number of risks, including the risk that:

 

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we do not control the amount and timing of resources that our strategic partners may devote to our products;

 

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we do not control the decision to pursue a product, the timing of product launches and extent of marketing and sales activities;

 

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  Ÿ  

our strategic partners may experience financial difficulties;

 

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we may be required to relinquish important rights such as marketing and distribution rights;

 

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business combinations or significant changes in a partner’s business strategy may also adversely affect a collaborator’s willingness or ability to complete its obligations under any arrangement;

 

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a collaborator could independently move forward with a competing product developed either independently or in collaboration with others, including our competitors; and

 

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collaborative arrangements are often terminated or allowed to expire, which would delay the development and may increase the cost of developing our products.

Allegedly defective design or the manufacture of allegedly defective test strips could potentially expose us to substantial costs, write-offs and reputational damage.

Allegedly defective designs or manufacture of allegedly defective products exposes us to the risk of product liability claims and product recalls, resulting in substantial costs, write-offs and potential delays in our shipment of product to customers, decreased demand for products, loss of revenue and cash flow, reputational damage, costs of related litigation, increases in our insurance premiums and increased scrutiny by regulatory agencies, claims by our customers and may trigger the dissolution of partnerships or collaborative relationships. While we will seek to mitigate our loss by obtaining appropriate insurances, if we are unable to maintain our insurance at an acceptable cost or on acceptable terms with adequate coverage or otherwise protect against potential product liability claims, we will be exposed to significant liabilities. This may harm our business and compromise the performance of our obligations to our customers and would have a material adverse effect on our business and financial results and may result in claims by our customers or partners and may trigger the dissolution of partnerships or collaborative relationships. Any claim for damages by our customers or other claim against us could be substantial.

There are many elements to manufacturing products that can cause variability beyond acceptable limits. We may be required to discard defective products after we have incurred significant material and labor costs, resulting in manufacturing delays and delayed shipment to customers. Further, if our suppliers are unable to provide materials in conformance with specifications, we may be required to discard materials, which may also cause delays in the manufacture and shipment of products.

Reduced margins would have a material adverse effect on our business and financial position.

Our margins may be reduced and costs increased which would have a material adverse effect on our business and financial position. The two primary factors that pose this risk include increased manufacturing costs or currency fluctuations.

Increases in our costs to manufacturing products or conducting development work may decrease our margins or cause us to suffer a loss on the manufacture products. Additionally, we may suffer decreased margins due to the global reach of our business exposing us to market risk from changes in foreign currency exchange rates. While the majority of our cash reserves and expenses are in Australian dollars, we continue to deal in other currencies, particularly in the United States and Europe, which may increase costs and decrease revenues incurred in foreign currencies. Additionally, we use, from time to time, financial instruments, primarily foreign currency forward contracts to hedge certain forecasted foreign currency commitments arising from trade accounts receivables, trade accounts payable and fixed purchase obligations. These hedging activities are largely dependent upon the accuracy of our forecasts and as such, our foreign currency forward contracts may not cover our full exposure to exchange rate fluctuations. Although we believe our foreign exchange policies are reasonable and prudent under the circumstances, we may experience losses from un-hedged currency fluctuations, which could be significant. If our costs increase or our margins decrease, it would have an adverse effect on our business and financial position.

New product design and development and clinical testing is costly, labor intensive and the outcomes uncertain.

The design and development of different tests on our platform takes a number of years to complete, is costly and the outcomes are uncertain. Although development risk generally reduces the further a test is developed, the tests we develop have a significant degree of technical risk, and irrespective of the stage of development, design

 

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and development work and product validation, the development of the test may be unsuccessful or not warrant product commercialization. If development activities are unsuccessful, we may need to delay, reduce the scope of or eliminate some or all of our development programs and significant monies and management time invested may be rendered unproductive and worthless.

Our agreements with our customers generally contain milestone based payments, many of which are payable upon the achievement of technical development milestones. In the event we are not successful in achieving the development milestone, we will not receive the milestone payments which would have a material adverse effect on our revenue and financial position. Furthermore, if we are unable to develop a product for a customer, it may eliminate an important revenue stream for us which may result in us not being profitable, or trigger dissolution of partnerships or collaborative relationships.

Diagnostic devices must be tested for safety and performance in laboratory and clinical trials before regulatory clearance for marketing is achieved. Such studies are costly, time consuming and unpredictable. Clinical trials may not be successful and marketing authorization may not be granted which may result in us not being profitable, or trigger dissolution of partnerships or collaborative relationships. The outcome of early clinical trials may not be predictive of the success of later clinical trials. Failed clinical trials may result in considerable investments of time and money being rendered unproductive and worthless.

Additionally, unanticipated trial costs or delays could cause substantial additional expenditure that is not reimbursed by a partner, cause us to miss milestones which trigger a financial payment or cause us or a partner to delay or modify our plans significantly. This would harm our business, financial condition and results of operations.

If we cannot maintain our intellectual property rights, our ability to make or develop point-of-care tests would be restricted or eliminated, and the value of our technology and diagnostic tests may be adversely affected.

Our ability to obtain proprietary rights, maintain trade secret protection and operate without infringing the proprietary rights of third parties is an integral part of our business.

A number of companies, universities and research institutions have or may be granted patents that cover technologies that we need to complete development of a particular product. We may choose or be required to seek licenses under third party patents which would be costly, may not be available on commercially acceptable terms, or at all. Further, we may be unaware of other third party patents or proprietary rights that are infringed by our point-of-care tests.

Our diagnostic tests are based predominantly on intellectual property rights that have been licensed to us from LifeScan. If we were to breach the License Agreement and LifeScan were to validly terminate the agreement in response, it would seriously restrict or eliminate our ability to develop and commercialize our existing and future tests which would have a material adverse effect on us as it would eliminate our existing commercialization opportunities.

LifeScan has a considerable degree of control in the manner that the intellectual property licensed to us is maintained and protected and, as a result, we have reduced control with respect to the maintenance and protection of a large portion of our licensed patent portfolio. LifeScan is responsible for the prosecution and maintenance of the intellectual property it licenses to us and we are largely dependent on them to defend proceedings or prosecute infringers. Our business would be harmed if the licensed patents were infringed or misappropriated. Prosecuting third parties and defending ourselves against third-party claims would be costly, time consuming and divert management’s attention from our business, potentially leading to delays in our development or commercialization efforts. Additionally, if third parties made successful claims, we may be liable for substantial damages or license fees, be required to stop marketing the infringing product or take other actions that are adverse to our business.

Risks associated with regulatory clearance and changes to regulation.

The products we are involved in developing are medical devices and therefore subject to extensive regulation in all major markets. The process of obtaining regulatory clearance is costly and time consuming and there can be no assurance that the required regulatory clearances will be obtained. Products cannot be

 

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commercially sold without regulatory clearance. Our customers and partners may be unable to obtain the necessary clearances to sell or if the clearances are delayed, revoked or subject to unacceptable conditions, the product may not be able to be commercialized which would have a material adverse effect on us.

If we were required and able to change suppliers and third party contract manufacturers, applicable regulatory bodies may require new testing and compliance inspections and require that we demonstrate structural and functional comparability between the same products manufactured by different organizations, resulting in additional costs and potential delays which could be detrimental to our business.

Furthermore, regulation is ongoing and manufacturers and marketers of products are subject to continuous review and periodic inspections. Potentially costly responses may be required to be given by us and our customers including product modification, or post-marketing clinical trials as a condition of approval to further substantiate safety and efficacy or investigate issues of interest. If we or our customers fail to comply with applicable regulatory requirements it may result in fines, delays, suspensions of clearances, seizures, recalls of products, operating restrictions or criminal prosecutions and could have a material adverse effect on our operations. Additionally, changes in existing regulations or the adoption of new regulations could make regulatory compliance by us more difficult in future and could hamper our ability to produce our products when we require.

Risks associated with suppliers.

Similar to most major manufacturers in our industry, we are dependent upon our suppliers for certain raw materials and components. We have preferred suppliers, making us vulnerable to supply disruption, which could harm our business and delay manufacturing operations. We seek to enter into long term contractual arrangements with certain of our suppliers, however we may not always be able to do so on acceptable terms. We may not be able to guarantee the supply of certain of our materials which may in turn affect our ability to supply product to our customers. We may have difficulty locating alternative suppliers in a timely manner or on commercially acceptable terms, and switching components may require product redesign and further regulatory clearance which could significantly delay production. Likewise, our customers and partners are subject to supply risks which may delay their ability to supply customers with product which would impact our revenue and have a consequential adverse effect on our business and results of operations.

To the extent we agree to be responsible for manufacturing meters for any of our customers and partners, we anticipate that we will outsource the manufacture of these meters. There is no guarantee that we will be able to enter into any such arrangement on acceptable terms, if at all, and as a result there is a risk of lengthy and costly delays of bringing our products to market. Further, if our contract manufacturers fail to achieve and maintain required production yields or manufacturing standards, it could result in product withdrawals, delays, recalls, product liability claims and other problems that could seriously harm our business. Any meter shortages or manufacturing delays could result in delays or reduction in our revenues, with consequential adverse effect on our business and results of operations.

The success of our business is heavily dependent upon market factors such as growth of the point-of-care testing market and our ability to compete effectively within the highly competitive in vitro diagnostics market.

Our business success relies on the growth of both the existing and emerging point-of-care testing market. We cannot be sure that this market will grow as we anticipate. Such growth will require continued support and demand from payers, patients and health care professionals and the endorsement by professional bodies that influence the practice of medicine. Research and clinical data may not sufficiently support point-of-care testing, nor may the health economic benefits sufficiently support point-of-care testing as an alternative to current practice. Even if the data is compelling, significant resources may be required to educate users and change in practice may be slower and more costly than we anticipate. If point-of-care testing fails to be adopted at the rate we expect, the sector may remain unattractive to the size of partner we seek to attract and as a consequence, we may need to change our business model. This may require us to incur more cost and/or our anticipated growth will be adversely affected and our results will suffer.

 

 

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We may face intense competition in development, marketing and selling point-of-care tests.

The market for in vitro diagnostics is intensely competitive, price sensitive and subject to rapid change. We and our customers and partners may be unable to accurately anticipate changes in the markets and the direction of technological innovation and the demands of end users, competitors may develop improved technologies and the market place may conclude that our products are obsolete. Our larger competitors enjoy several competitive advantages including significantly greater financial resources, greater brand recognition, greater expertise in conducting clinical trials, obtaining regulatory approvals and managing manufacturing operations, and greater experience in product sales and marketing. Early-stage companies may also prove to be significant competitors.

Competition will be faced from existing products as well as products in development. Point-of-care tests are likely to experience significant and continuing competition from traditional pathology laboratory based testing as well as other point-of-care tests. Our and our customers’ and partners’ commercial opportunity will be reduced or eliminated if competitors develop and commercialize safer, more effective, more convenient, or cheaper products, or reach the market sooner than we do. Any such developments adversely affecting the market for products developed by us may force us and our partners to reduce production or discontinue manufacturing which would cause our operating results to suffer. There can be no assurances given with respect to our or any partner’s ability to compete effectively in the competitive markets in which we operate.

We face risks manufacturing product for partners.

There are technical challenges establishing and maintaining commercial manufacturing for products, including maintaining the consistency of our incoming raw materials, equipment design and automation, material procurement, production yields and quality control and assurance. We may fail to achieve and maintain required production yields or manufacturing standards which could result in patient injury or death, product recalls or withdrawals, product shortages, delays or failures in product testing or delivery, breach of our agreements with any partner and other problems that could seriously harm our business.

Adverse economic conditions may harm our business.

Market and economic conditions have been challenging worldwide. Continuing concerns have led to increased market volatility and diminished expectations for world economies. These factors may include fluctuations in foreign exchange rates, inflation, interest rates, rate of economic growth, taxation laws, consumer spending, unemployment rates, government fiscal, monetary and regulatory policies and consumer and business sentiment. Any of these factors have the potential to cause costs to increase or revenues to decline. Continued turbulence in the US and international markets and economies may adversely affect our ability to enter into collaborative arrangements, the behavior and financial condition of our current and any future customers and partners and the spending patterns of users of the products we are developing. This may adversely impact demand for our services and for products developed by us. In addition, economic conditions could also impact our suppliers, which may impact on their ability to provide us with materials and components which in turn may negatively impact our business.

We may not be able to raise capital or secure credit if and when required.

We may not be able to raise capital or secure credit if and when required. If we are unable to raise capital or secure credit when required, we may have to delay, reduce the scope of or eliminate some or all of our development programs or commercialization efforts or liquidate some or all of our assets.

The loss of a key employee or the inability to recruit and retain high caliber staff to manage future anticipated growth could have a material adverse effect on our business.

As with most growth companies, our future success is substantially dependent on our key personnel. Certain key personnel would be difficult to replace and the loss of any such key personnel may adversely impact the achievement of our objectives. Our ability to operate successfully and manage the business depends significantly on attracting and retaining additional highly qualified personnel. The loss of any key personnel may be disruptive or have a material adverse effect on the future of our business. The competition for qualified employees in scientific research and medical diagnostic industries is particularly intense and there are a limited number of persons with the necessary skills and experience.

 

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Our primary operations are conducted at a single location. Any disruption at our facility could adversely affect our operations and increase our expenses.

Our primary operations are conducted at our Corporate Avenue facility in Melbourne, Australia. We take precautions to safeguard our facility, including security, health and safety protocols and maintain applicable insurance. However, we may be impacted by industrial action or operating equipment and facilities may not operate as intended or be available as a result of unanticipated failures or other events outside of our control such as a natural disaster, fire, flood or earthquake or catastrophic breakdowns or deliberate acts of destruction. The occurrence of any of these event may restrict our ability to supply product, could cause substantial delays in our operations, damage or destroy our manufacturing equipment or inventory, and cause us to incur additional expenses. The insurance we maintain against fires, floods, earthquakes and other natural disasters may not be adequate to cover our losses in any particular case.

Investors may be subject to Australian and/or US taxation.

The receipt of dividends by Australian tax resident security holders and any subsequent disposal of our securities by Australian tax resident may have both United States and Australian tax consequences depending upon their individual circumstances. This may result in a security holder being subject to tax in both jurisdictions and a tax credit may or may not be available in one jurisdiction to offset the tax paid in the other jurisdiction depending upon the security holder’s individual circumstances.

The price of our shares is highly volatile and could decline significantly.

Our shares of common stock in the form of CDIs were quoted on the ASX and began trading on December 13, 2006. The price of our shares is highly volatile and could decline significantly. The market price of our shares historically has been, and we expect will continue to be, subject to significant fluctuations over short periods of time. These fluctuations may be due to factors specific to us, to changes in analysts’ recommendations and earnings estimates, or to factors affecting the life sciences industry or the securities markets in general. For example, from the initial quotation of our shares in the form of CDIs on the Australian Securities Exchange on December 13, 2006 until March 6, 2012, the closing price per share of our shares ranged from a low of A$0.41 during February 2009 to a high of A$2.02 during the first quarter of the 2010 fiscal year and was A$0.80 on March 6, 2012. We may experience a material decline in the market price of our CDIs, regardless of our operating performance and therefore, a holder of our shares may not be able to sell those shares at or above the price paid by such holder for such shares. Sales by our larger shareholders may create volatility or impact how the value of our shares is perceived.

Class action litigation has been brought in the past against companies which have experienced volatility in the market price of their securities. We may become involved in this type of litigation in the future. Litigation of this type is often extremely expensive and diverts management’s attention and our resources.

Our securities are not currently traded on any United States public markets and there are currently restrictions on the ability of United States persons to acquire our securities on the ASX.

There is no public market for our shares in the United States or in any other jurisdiction other than Australia. We have not determined whether we will seek the quotation of our shares on any United States public trading market. Even if our shares are in the future listed on a United States public market, the liquidity of our shares may not improve, and the United States market price may not accurately reflect the price or prices at which purchasers or sellers would be willing to purchase or sell our common stock.

In addition, a substantial number of our shares are “restricted securities” and resale of these shares to “U.S. Persons” as defined in Regulation S of the Securities Act of 1933 may only occur in a limited number of specified circumstances.

We may be involved in litigation

There has been substantial litigation and other proceedings in the medical diagnostic industries. Defending against litigation and other third party claims would be costly and time consuming and would divert

 

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management’s attention from our business, which could lead to delays in our development or commercialization efforts. If third parties are successful in their claims, we might have to pay substantial damages or take other actions that are adverse to our business.

Changes in laws may adversely affect our business.

Our business and the business of our customers and partners are subject to the laws and regulations in a number of jurisdictions. Unforeseen changes in laws and government policy both in Australia, the EU, the US and elsewhere, could materially impact our’ operations, assets, contracts and profitability.

We are exposed to risks relating to evaluations of controls required by Section 404 of the Sarbanes-Oxley Act.

Changing laws, regulations and standards relating to corporate governance and public disclosure, including the Sarbanes-Oxley Act of 2002 (“Sarbanes-Oxley Act”) and related regulations implemented by the SEC, have substantially increased legal and financial compliance costs. We expect that our ongoing compliance with applicable laws and regulations, including the Securities Exchange Act of 1934 as amended (“Exchange Act”) and the Sarbanes-Oxley Act, will involve significant and potentially increasing costs. In particular, we must annually evaluate our internal controls systems to allow management to report on our internal controls. Additionally, as an “accelerated” filer with the SEC, our independent auditors must attest to our internal controls. We must perform the system and process evaluation and testing (and any necessary remediation) required to comply with the management certification and, when applicable, auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act. If we are not able to continue to satisfy the requirements of Section 404 adequately, we may be subject to sanctions or investigation by regulatory authorities, including the SEC. Any action of this type could adversely affect our financial results, investors’ confidence in our company and our ability to access capital markets, and could cause our stock price to decline.

A significant amount of our shares are controlled by individuals or voting blocks, and the interests of such individuals or voting blocks could conflict with those of the other stockholders.

Single stockholders with significant holdings or relatively small groups of stockholders have the power to influence matters requiring the approval of stockholders. Approximately 11.7% of our outstanding shares of common stock are owned by The Principals Cornerstone Fund Pty Ltd, an Australian company, which holds shares on trust for our directors, Messrs Denver, Hanley and Dr. Adam. These directors also hold shares directly and through other vehicles. In addition, a company called PFM Cornerstone Limited, an Australian company, of which Messrs Denver, Hanley and Dr. Adam are directors, holds approximately 7.6% of our shares. Mr. Andrew Jane is one of our directors and a director of CM Capital Investments Pty Ltd which holds approximately 11.2% of our shares. As directors, these individuals have the power to influence significantly all matters requiring the

approval of our stockholders, including the election of directors and the approval of other significant resolutions, and their interests may conflict with those of the other stockholders. In addition, control of a significant amount of our common stock by insiders could adversely affect the market price of shares. Based on the latest Amendment to Schedule 13G filed on January 25, 2012, Johnson and Johnson Development Corporation (a venture capital wholly owned subsidiary of Johnson & Johnson) beneficially held 14,915,400 shares in the Company as at December 31, 2011 which represents approximately 9.4% of the Company’s shares. For details of our substantial stockholders and the interests of our directors, refer to “Item 12 — Security Ownership of Certain beneficial Owners and Management and Related Stockholder Matters”.

We have never paid a dividend and we do not intend to pay dividends in the foreseeable future which means that holders of shares of common stock and CDIs may not receive any return on their investment from dividends.

To date, we have not declared or paid any cash dividends on our shares or CDIs and currently intend to retain any future earnings, if any, for funding growth. We do not anticipate paying any dividends in the foreseeable future.

 

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Our holders of CDIs are not stockholders and do not have stockholder rights.

The main difference between holding CDIs and holding our underlying shares is that a CDI holder has beneficial ownership of the equivalent number of shares instead of legal title. CDIs are exchangeable, at the option of the holder, into shares of our common stock at a ratio of 1:1. Legal title is held by CHESS Depositary Nominees Pty Ltd (“CDN”) and the shares are registered in the name of CDN and held by CDN on behalf of and for the benefit of CDI Holders. CDN is a wholly owned subsidiary of ASX. CDI holders will be entitled to all the economic benefits of the shares underlying their CDIs, such as dividends (if any), bonus issues or rights issues. CDN as a stockholder of record will receive notice of stockholder meetings and be entitled to attend and vote at stockholder meetings. CDI holders will likewise be sent notices of stockholder meetings and are entitled to attend stockholder meetings but are not permitted to vote other than by giving directions on how to vote to CDN or as a proxy holder for CDN.

Our success is dependent on the accuracy, reliability and proper use of sophisticated information processing systems and management information technology and the interruption in these systems could have a material adverse effect on our business, financial condition and results of operations.

Our success is dependent on the accuracy, reliability and proper use of sophisticated information processing systems and management information technology. Our information technology systems are designed and selected in order to facilitate the entering of order entry, customer billing, to maintain customer records, to provide product traceability, to accurately track purchases, to manage accounting, finance, administration and manufacturing, generate reports and provide customer service and technical support. Any interruption in these systems could have a material adverse effect on our business, financial condition and results of operations.

Provisions in our charter documents and under Delaware law could make the possibility of our acquisition, which may be beneficial for our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove current management.

Provisions in our certificate of incorporation and our bylaws may delay or prevent an acquisition of us or a change in our management, and frustrate or prevent attempts by our stockholders to replace or remove our current management by making it more difficult to remove our current directors. Such provisions include:

 

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the division of our Board into classes whose terms expire at staggered intervals over a three year period and advance notice requirements for nominations to our Board and proposing matters that can be acted upon at shareholder meetings;

 

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the requirement that actions by our stockholders by written consent be unanimous;

 

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the ability of our Board to issue preferred stock.

Limitation on Independent Registered Public Accounting Firm’s Liability.

The Australian accounting firm we utilize for audit reports on our financial statements is subject to limitations on liability with respect to claims arising out of their audit reports, in accordance with professional standards legislation. This legislation may limit the liability of our accountant’s for damages with respect to certain civil claims arising directly or vicariously from anything done or omitted in the performance of their professional services to us, including to the lesser of (in the case of audit services) ten times the reasonable charge for the service provided and a maximum liability for audit work of A$75 million or, in relation to matters occurring prior to October 7, 2007, A$20 million. The limit does not apply to claims for breach of trust, fraud or dishonesty.

These limitations of liability may limit recovery upon the enforcement in Australian courts of any judgment under US or other foreign laws rendered against our Australian accountants based on or related to their audit report on our financial statements. Substantially all of our accountant’s assets are located in Australia. However, the professional standards legislation has not been subject to judicial consideration and therefore how the limitation will be applied by the courts and the effect of the limitation on the enforcement of foreign judgments are untested.

ITEM 1B.     UNRESOLVED STAFF COMMENTS.

None.

 

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ITEM 2.     PROPERTIES.

Universal Biosensors Pty Ltd leases approximately 5,000 square meters of office, research and development and manufacturing facilities at 1 Corporate Avenue, Rowville in Melbourne, Australia. The lease for the premises at 1 Corporate Avenue Rowville expires on March 31, 2014 with two options to renew the lease for successive five year periods.

We manufacture our test strips using custom manufacturing equipment.

Depending on the number of strips required to be manufactured, it may become necessary in the future for us to acquire additional large scale equipment to satisfy manufacturing demand. If our existing facilities and equipment are fully utilized for the manufacture of test strips for one of our customers or partners, we will need to secure additional or alternative facilities and establish additional large scale equipment sufficient to future manufacturing requirements.

ITEM 3.     LEGAL PROCEEDINGS.

There are no material legal or arbitration proceedings pending against us or Universal Biosensors Pty Ltd.

ITEM 4.     MINE SAFETY DISCLOSURES

Not applicable

PART II

ITEM 5.     MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES.

Market information

Our shares of common stock are not currently traded on any established United States public trading market. We have not determined whether we will seek the quotation of our shares of common stock on any United States public trading market. We cannot assure you that we will seek to be quoted on any United States public trading market or that we would meet any applicable listing requirements.

Our shares of common stock are traded on the ASX in the form of CHESS Depositary Interests, or CDIs, under the ASX trading code “UBI”. The Clearing House Electronic Subregister System, or “CHESS”, is an electronic system which manages the settlement of transactions executed on the ASX and facilitates the paperless transfer of legal title to ASX quoted securities. CHESS cannot be used directly for the transfer of securities of companies, such as us, that are domiciled in countries whose laws do not recognize uncertificated holdings or electronic transfer of legal title. CDIs are used as a method of holding and transferring the legal title of these securities on the ASX which are not able to be electronically traded in CHESS. CDIs are exchangeable, at the option of the holder, into shares of our common stock at a ratio of 1:1. The main difference between holding CDIs and holding the underlying securities (in this case our shares) is that a holder of CDIs has beneficial ownership of the equivalent number of our shares instead of legal title. Legal title is held by CHESS Depositary Nominees Pty Ltd, or CDN, and the shares are registered in the name of CDN and held by CDN on behalf of and for the benefit of the holders of CDIs. CDN is a wholly owned subsidiary of ASX.

Holders of CDIs who do not wish to have their trades settled in CDIs on the ASX may request that their CDIs be converted into shares, in which case legal title to the shares of common stock are transferred to the holder of the CDIs. Likewise, stockholders who wish to be able to trade on the ASX can do so by requesting that their shares be converted into CDIs and by lodging their applicable share certificate with our share registrar and signing a share transfer form with respect to the relevant shares. Our share registrar will then transfer the shares from the stockholder to CDN and establish a CDI holding in the name of the stockholder (now a CDI holder).

High and low sale prices of our CDIs on the ASX

The sale prices of our shares traded in the form of CDIs are quoted on the ASX in Australian dollars. Our CDIs were first quoted on the ASX on December 13, 2006. Twenty minute delayed trading prices of our CDIs are available through the ASX at www.asx.com.au.

 

 

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The following tables sets forth, for the periods indicated, the highest and lowest market prices in Australian dollars for our CDIs reported on the ASX:

 

      High A$      Low A$  

Fiscal Year 2011

     

First Quarter

   A$ 1.59       A$ 1.23   

Second Quarter

   A$ 1.40       A$ 0.90   

Third Quarter

   A$ 1.19       A$ .083   

Fourth Quarter

   A$ 0.94       A$ 0.72   

Fiscal Year 2010

     

First Quarter

   A$ 2.02       A$ 1.60   

Second Quarter

   A$ 1.75       A$ 1.30   

Third Quarter

   A$ 1.68       A$ 1.40   

Fourth Quarter

   A$ 1.65       A$ 1.35   

Security details

As of March 6, 2012, there were 159,146,213 shares of our common stock issued and outstanding and 11,258,290 employee options that are exercisable for an equivalent number of shares of common stock (7,854,111 of which were exercisable or exercisable within 60 days thereafter). All of our issued and outstanding shares of common stock are fully paid.

Under applicable U.S. securities laws all of the shares of our common stock are “restricted securities” as that term is defined in Rule 144 under the Securities Act. Restricted securities may be resold to U.S. persons as defined in Regulation S only if registered or if they qualify for an exemption from registration under the Securities Act, each as described in more detail below. We have not agreed to register any of our common stock for resale by security holders.

Rule 144(b)

Because there is no public trading market for the shares in the United States, no sales in the United States under Rule 144 other than Rule 144(b)(1)(i) are likely to occur. Under Rule 144(b)(1)(i), a person who is not deemed to have been an affiliate of ours at any time during the 90 days preceding a sale, and who has beneficially owned the shares proposed to be sold for between six months and one year may sell so long as the public information requirements of Rule 144 are satisfied, and, after one year, such person is entitled to sell the shares without having to comply with the manner of sale, public information or provisions of Rule 144. A person who is deemed an affiliate during the 90 days preceding the sale who has beneficially owned the shares proposed to be sold for at least six months may sell so long as the conditions of Rule 144 are met, including the manner of sale, public information, volume limitation and notice filing provisions of Rule 144.

Holders

Currently, CDN holds the majority of our shares on behalf of and for the benefit of the holders of CDIs. The balance of the shares are held by certain of our employees. Set out below is the aggregate number of our registered holders of CDIs and shares at the specific date below:

 

Date

   Total Number of
Registered Holders
   Number of Holders that
are United States
Residents

At March 6, 2012

   1,507    8

Dividends

To date, we have not declared or paid any cash dividends on our shares or CDIs and currently intend to retain any future earnings, if any, for funding growth. We do not anticipate paying any dividends in the foreseeable future.

 

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Securities authorized for issuance under equity compensation plans

Set out below are details of our Employee Option Plan as at December 31, 2011.

 

     Equity Compensation Plan Information  

Plan Category

   Number of securities to be
issued upon exercise of
outstanding options,
warrants and rights
     Weighted average exercise
price of outstanding

options, warrants and rights
     Number of Securities
remaining for future

issuance
 
            (A$)         

Equity compensation plans approved by security holders

     11,417,536         1.02         (1

Equity compensation plans not approved by security holders

                     (1
  

 

 

    

 

 

    

Total

     11,417,536         1.02      
  

 

 

    

 

 

    

 

(1) The number of employee options able to be granted is limited to the amount permitted to be granted at law, the ASX Listing Rules and by the limits on our authorized share capital in our certificate of incorporation. The Listing Rules of ASX generally prohibit companies whose securities are quoted on the ASX from issuing securities exceeding 15% of issued share capital in any 12 month period, without stockholder approval.

 

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Table of Contents

Recent Sales of Unregistered Securities; Use of Proceeds from Registered Securities

Exercise of Employee Stock Options

The table below sets forth the number of employee stock options exercised and the number of shares of common stock issued in the period from January 1, 2009 to December 31, 2011. We issued these shares in reliance upon exemptions from registration under Regulation S under the Securities Act of 1933, as amended.

 

Period Ending

   Number of Options
Exercised and
Corresponding Number
of Shares Issued
     Option Exercise Price      Proceeds Received  
                   (A$)  

2009

        

August, 2009

     36,248         A$0.31         11,221   

September, 2009

     25,374         A$0.31         7,853   

November, 2009

     13,332         A$0.89         11,865   

November, 2009

     25,373         A$0.28         7,059   

November, 2009

     8,000         A$0.70         5,600   

November, 2009

     30,000         A$1.18         35,400   
  

 

 

       

 

 

 
     138,327            78,998   
  

 

 

       

 

 

 

2010

        

February, 2010

     23,333         A$0.89         20,766   

February, 2010

     20,000         A$0.94         18,800   

February, 2010

     4,000         A$0.50         2,000   

February, 2010

     18,124         US$0.26         5,104   

February, 2010

     13,332         A$1.18         15,732   

February, 2010

     18,124         US$0.22         4,489   

February, 2010

     33,333         Nil           

March, 2010

     6,666         A$0.89         5,933   

March, 2010

     6,666         A$0.70         4,666   

March, 2010

     2,000         A$0.94         1,880   

May, 2010

     12,500         Nil           

June, 2010

     6,667         A$0.94         6,267   

June, 2010

     20,000         US$0.22         4,040   

August, 2010

     25,374         US$0.26         8,381   

August, 2010

     20,000         A$1.18         23,600   

August, 2010

     13,332         A$0.89         11,865   

August, 2010

     6,667         A$0.94         6,267   

September, 2010

     13,333         A$0.94         12,533   

September, 2010

     8,000         A$0.70         5,600   

September, 2010

     16,666         A$1.20         19,999   

September, 2010

     3,333         A$0.94         3,133   

October, 2010

     960,560         US$0.26         256,018   

October, 2010

     45,000         A$1.18         53,100   

October, 2010

     100,000         A$0.89         89,000   

November, 2010

     181,238         US$0.26         47,430   

November, 2010

     28,000         A$1.18         33,040   

November, 2010

     40,000         A$0.89         35,600   

November, 2010

     21,333         A$0.94         20,053   
  

 

 

       

 

 

 
     1,667,581            715,296   
  

 

 

       

 

 

 

 

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2011

        

January, 2011

     50,000         A$0.89         44,500   

January, 2011

     13,333         A$0.50         6,667   

January, 2011

     26,667         Nil           

January, 2011

     6,666         A$0.94         6,266   

March, 2011

     40,000         US$0.22         8,694   

May, 2011

     6,667         A$0.70         4,667   

May, 2011

     2,333         A$0.94         2,193   

August, 2011

     8,000         A$0.50         4,000   

November, 2011

     10,000         US$0.26         2,518   

November, 2011

     18,333         Nil           
  

 

 

       

 

 

 
     181,999            79,504   
  

 

 

       

 

 

 

The funds raised have been and will be used for working capital requirements including the continued development of our existing pipeline of point-of-care tests and to identify and develop additional tests.

Restricted Employee Shares Issued to Employees

Our Employee Share Plan was adopted by the Board of Directors in 2009. The Employee Share Plan permits our Board to grant shares of our common stock to our employees and directors. The number of shares able to be granted is limited to the amount permitted to be granted at law, the ASX Listing Rules and by the limits on our authorized share capital in our certificate of incorporation. All our employees are eligible for shares under the Employee Plan. The Company currently proposes to issue A$1,000 worth of restricted shares of common stock to employees of the Company on a recurring basis, but no more frequently than annually. The restricted shares have the same terms of issue as our existing shares of common stock but are not able to be traded until the earlier of three years from the date on which the shares are issued or the date the relevant employee ceases to be an employee of the Company or any of its associated group of companies. We issue these shares in reliance upon exemptions from registration under Regulation S under the Securities Act of 1933, as amended.

The table below sets forth the restricted shares issued by the Company:

 

     Number of Restricted
Shares Issued
     Market Value of
Restricted Shares
Issued
 

November, 2009

     40,670       A$ 69,952   

May, 2010

     581       A$ 999   

November, 2010

     47,400       A$ 74,892   

November, 2011

     86,471       A$ 76,959   

Restricted stock awards activity during the current period is as follows:

 

     Number of shares     Weighted average
issue price

A$
 

Balance at December 31, 2010

     82,841        1.64   
  

 

 

   

 

 

 

Granted

     86,471        0.89   

Release of restricted shares

     (11,549     1.64   
  

 

 

   

 

 

 

Balance at December 31, 2011

     157,763        1.23   
  

 

 

   

 

 

 

Purchases of Equity Securities by the Issuer and Affiliated Purchasers

There were no repurchases of equity securities in 2011.

 

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Table of Contents
ITEM 6.    SELECTED FINANCIAL DATA.

The following table represents our selected financial data for the dates and periods indicated.

 

     Years Ended December 31,  
     2011     2010     2009     2008     2007  
     A$     A$     A$     A$     A$  

Revenue

          

Revenue from products

   $ 12,063,582      $ 11,760,009      $ 132,733      $      $   

Revenue from services

     2,632,870        6,420,027        2,850,071        3,121,754          

Research and development income

                   1,337,125        1,170,190        1,192,015   

Milestone payment

                   17,722,641                 
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

     14,696,452        18,180,036        22,042,570        4,291,944        1,192,015   

Operating costs & expenses

          

Cost of goods sold

     12,310,302        10,801,062        458,162                 

Cost of services

     708,149        1,481,674        169,241        3,121,754          

Research and development

     9,812,396        6,482,150        14,898,072        11,585,258        7,157,216   

General and administrative

     7,271,488        7,185,550        5,635,569        5,510,127        4,226,757   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total operating costs & expenses

     30,102,335        25,950,436        21,161,044        20,217,139        11,383,973   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Profit/(loss) from operations

     (15,405,883     (7,770,400     881,526        (15,925,195     (10,191,958

Other income/(expense)

          

Interest income

     683,323        1,192,889        809,459        2,542,060        1,440,102   

Interest expense

                   (9,636     (9,489       

Fee income

                          1,131,222          

Other

     30,443        (33,014     (250,886     265,310        (210,382
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total other income/(expense)

     713,766        1,159,875        548,937        3,929,103        1,229,720   

Net profit/(loss) before tax

     (14,692,117     (6,610,525     1,430,463        (11,996,092     (8,962,238

Income tax benefit/(expense)

                          206        145,000   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net profit/(loss)

   $ (14,692,117   $ (6,610,525   $ 1,430,463      $ (11,995,886   $ (8,817,238
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Basic net profit/(loss) per share

   $ (0.09   $ (0.04   $ 0.01      $ (0.08   $ (0.07

Average weighted number of shares —basic

     159,017,777        157,584,044        157,013,578        156,970,679        129,637,286   

Diluted net profit/(loss) per share

   $ (0.09   $ (0.04   $ 0.01      $ (0.08   $ (0.07

Average weighted number of shares —diluted

     159,017,777        157,584,044        161,354,802        156,970,679        129,637,286   

 

     Years Ended December 31,  
     2011      2010      2009      2008      2007  
     A$      A$      A$      A$      A$  

Balance Sheet Data:

              

Cash and cash equivalents

     15,089,209         23,271,766         31,291,011         28,334,864         41,958,285   

Total assets

     45,216,467         53,837,949         56,083,468         52,505,321         63,512,160   

Long-term debt

                                       

Convertible preference shares

                                       

Total stockholders’ equity

     35,022,606         47,219,079         51,314,002         48,703,230         59,749,624   

 

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Total Return Stock Performance Graph

The following line graph compares the cumulative total stockholder return on our common stock from December 31, 2006 through December 31, 2011 with the cumulative total return of a major market index and a published industry index. The graph below assumes an investment of A$100.00 on December 31, 2006 in our common stock, and compares its performance with the Standard and Poor’s 500 Index and the Standard and Poor’s 500 Health Care Index. We paid no dividends on our common stock during the period covered by the graph. The Indices included in the graph reflect a cumulative total return based upon the reinvestment of dividends of the stocks included in those indices. Measurement points are December 31, 2006 and the last trading day of each subsequent year end through December 31, 2011.

 

LOGO

The comparisons shown in the graph above are based upon historical data. The stock price performance shown in the graph is not necessarily indicative of, nor is it intended to forecast, the potential future performance of our common stock. This graph shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, or otherwise subject to the liabilities of that section, and will not be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

ITEM 7.     MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The information required by this item is incorporated by reference to our 2011 Annual Report under the caption “Management’s Discussion and Analysis of Financial Condition and Results of Operations” on pages F-2 to F-10.

ITEM 7A.     QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

The information required by this item is incorporated by reference to our 2011 Annual Report under the caption “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Financial Risk Management” on page F-10.

 

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ITEM 8.     FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

We refer you to the “Consolidated Balance Sheets”, “Consolidated Statements of Operations”, “Consolidated Statements of Stockholders’ Equity and Comprehensive Income”, “Consolidated Statements of Cash Flows”, and “Notes to Consolidated Financial Statements”, on pages F-13 through F-36, and “Report of Independent Registered Public Accounting Firm” on pages F-11 through F-12 of our Annual Report to Stockholders for the fiscal year ended December 31, 2011, which sections are incorporated by reference herein.

Supplementary Financial Information

The following is a summary of the unaudited quarterly results of operations:

 

     Year ended December 31, 2011  
     Quarter
Ended
March 31
    Quarter
Ended
June 30
    Quarter
Ended
September  30
    Quarter
Ended
December  31
 
     A$     A$     A$     A$  

Revenue

        

Revenue from products

   $ 3,319,401      $ 2,267,766      $ 2,153,518      $ 4,322,897   

Revenue from services

     245,920        476,129        318,869        1,591,952   

Research and development income

                            

Milestone payment

                            
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

     3,565,321        2,743,895        2,472,387        5,914,849   

Operating costs & expenses

        

Cost of goods sold

     3,492,052        2,694,792        2,314,082        3,809,376   

Cost of services

     63,519        140,987        61,257        442,386   

Research and development

     1,747,507        2,969,982        2,317,556        2,777,351   

General and administrative

     1,405,358        1,800,900        2,029,467        2,035,763   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating costs & expenses

     6,708,436        7,606,661        6,722,362        9,064,876   
  

 

 

   

 

 

   

 

 

   

 

 

 

Profit/(loss) from operations

     (3,143,115     (4,862,766     (4,249,975     (3,150,027

Other income/(expense)

        

Interest income

     224,875        179,444        145,228        133,776   

Interest expense

                            

Fee income

                            

Other

     (128,992     (226,486     749,727        (363,806
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other income/(expense)

     95,883        (47,042     894,955        (230,030

Net profit/(loss) before tax

     (3,047,232     (4,909,808     (3,355,020     (3,380,057

Income tax benefit/(expense)

                            
  

 

 

   

 

 

   

 

 

   

 

 

 

Net profit/(loss)

   $ (3,047,232   $ (4,909,808   $ (3,355,020   $ (3,380,057
  

 

 

   

 

 

   

 

 

   

 

 

 

Basic and diluted net loss per share

   $ (0.02   $ (0.03   $ (0.02   $ (0.02

Average weighted number of shares used as denominator

     158,952,569        159,012,414        159,022,118        159,082,531   

Diluted net profit/(loss) per share

   $ (0.02   $ (0.03   $ (0.02   $ (0.02

Average weighted number of shares used as denominator

     158,952,569        159,012,414        159,022,118        159,082,531   

 

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Table of Contents

 

     Year ended December 31, 2010  
     Quarter
Ended
March 31
    Quarter
Ended
June 30
    Quarter
Ended
September  30
    Quarter
Ended
December  31
 
     A$     A$     A$     A$  

Revenue

        

Revenue from products

   $ 1,524,813      $ 1,359,584      $ 3,202,873      $ 5,672,739   

Revenue from services

     1,893,133        1,403,779        1,785,331        1,337,784   

Research and development income

                            

Milestone payment

                            
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

     3,417,946        2,763,363        4,988,204        7,010,523   

Operating costs & expenses

        

Cost of goods sold

     1,538,436        1,936,716        3,136,390        4,189,520   

Cost of services

     246,064        247,190        376,398        612,022   

Research and development

     1,554,227        1,799,551        1,543,482        1,584,890   

General and administrative

     1,469,609        1,788,984        1,675,868        2,251,089   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating costs & expenses

     4,808,336        5,772,441        6,732,138        8,637,521   
  

 

 

   

 

 

   

 

 

   

 

 

 

Profit/(loss) from operations

     (1,390,390     (3,009,078     (1,743,934     (1,626,998

Other income/(expense)

        

Interest income

     305,019        327,949        289,296        270,625   

Interest expense

                            

Fee income

                            

Other

     (10,291     153,984        (47,473     (129,234
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other income/(expense)

     294,728        481,933        241,823        141,391   

Net profit/(loss) before tax

     (1,095,662     (2,527,145     (1,502,111     (1,485,607

Income tax benefit/(expense)

                            
  

 

 

   

 

 

   

 

 

   

 

 

 

Net profit/(loss)

   $ (1,095,662   $ (2,527,145   $ (1,502,111   $ (1,485,607
  

 

 

   

 

 

   

 

 

   

 

 

 

Basic and diluted net loss per share

   $ (0.01   $ (0.02   $ (0.01   $ (0.01

Average weighted number of shares used as denominator

     157,229,023        157,307,199        157,378,290        158,403,507   

 

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Table of Contents

 

ITEM 9.     CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

None.

ITEM 9A.     CONTROLS AND PROCEDURES

Disclosure Controls and Procedures.    At the end of the period covered by this report, the Company evaluated the effectiveness of the design and operation of its disclosure controls and procedures. The Company’s disclosure controls and procedures are designed to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the Company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Paul Wright, Chief Executive Officer, and Salesh Balak, Chief Financial Officer, reviewed and participated in this evaluation. Based on this evaluation, Messrs. Wright and Balak concluded that, as of the end of the period covered by this report, the Company’s disclosure controls and procedures were effective.

Changes in Internal Control Over Financial Reporting.    During the fiscal quarter ended December 31, 2011, there were no changes in the Company’s internal control over financial reporting identified in connection with the evaluation of such referred to above in this Item 9A that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

 

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MANAGEMENT’S REPORT ON INTERNAL CONTROL OVER FINANCIAL REPORTING

Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act). Our internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that:

 

  Ÿ  

Pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and the dispositions of the assets of the Company;

 

  Ÿ  

Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the Company are being made only in accordance with authorizations of management and the board of directors of the Company; and

 

  Ÿ  

Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the Company’s assets that could have a material effect on the financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluations of effectiveness to future periods are subject to risk that controls may become inadequate because of changes in conditions or because of declines in the degree of compliance with the policies or procedures.

Our management, with the participation of the Principal Executive Officer and Principal Financial Officer, assessed the effectiveness of the Company’s internal control over financial reporting as of December 31, 2011. In making this assessment, the Company’s management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”) in Internal Control-Integrated Framework.

Based on this evaluation, our management, with the participation of the Principal Executive Officer and Principal Financial Officer, concluded that, as of December 31, 2011, our internal control over financial reporting was effective.

The effectiveness of the Company’s internal control over financial reporting as of December 31, 2011 has been audited by PricewaterhouseCoopers, an independent registered public accounting firm, as stated in their report, which appears in the “Report of Independent Registered Public Accounting Firm” on pages F-11 to F-12 of the Annual Report, which is incorporated herein by reference and filed as Exhibit 13 to this Report on Form 10-K.

 

/s/ Paul Wright

   /s/ Salesh Balak                 

Paul Wright

   Salesh Balak                       

Principal Executive Officer

   Principal Financial Officer
March 13, 2012   

 

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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM ON INTERNAL CONTROL OVER FINANCIAL REPORTING

We refer you to “Report of Independent Registered Public Accounting Firm” on pages F-11 to F-12 of our Annual Report to Stockholders for the fiscal year ended December 31, 2011, which are incorporated by reference herein, for the Independent Registered Public Accounting Firm’s report with respect to the effectiveness of internal control over financial reporting.

 

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ITEM 9B.     OTHER INFORMATION

None.

PART III

ITEM 10.     DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.

The information required by this item regarding our directors and executive officers is incorporated by reference to our Definitive Proxy Statement to be filed with the Securities and Exchange Commission in connection with our Annual Meeting of Stockholders in 2012 (the “2012 Proxy Statement”) under the caption “Management of the Company.”

The information required by this item regarding “Compliance with Section 16(a) of the Exchange Act” is incorporated by reference to the 2012 Proxy Statement under the caption “Other Matters — Section 16(a) Beneficial Ownership Reporting Compliance.”

We have adopted our Code of Ethics for Senior Financial Officers, a code of ethics that applies to our Principal Executive Officer and Principal Financial Officer. This code of ethics may be accessed and reviewed through our website at www.universalbiosensors.com. We intend to satisfy any disclosure requirement under item 5.05 of Form 8-K regarding an amendment to, or waiver from, a provision of the Code of Ethics for our Principal Executive Officer and Principal Financial Officer, by posting such information on our website at www.universalbiosensors.com

The information regarding the procedures by which security holders may recommend nominees to our Board of Directors is incorporated by reference to the 2012 Proxy Statement under the caption “Management of the Company — Board Committees — Remuneration and Nomination Committee.” There have been no material changes to the procedures by which security holders may recommend nominees to our Board of Directors.

The information required by this item regarding our Audit Committee is incorporated by reference to the 2012 Proxy Statement under the caption “Management of the Company — Board Committees — Audit and Compliance Committee.”

ITEM 11.     EXECUTIVE COMPENSATION.

The information required by this item is incorporated by reference to the 2012 Proxy Statement under the captions “Management of the Company — Compensation of Directors”, “Executive Compensation” and “Management of the Company — Board Committees — Compensation Committee Interlocks and Insider Participation.”

Discussions on the frequency of the shareholder advisory votes on executive compensation are incorporated by reference to the 2012 Proxy Statement under the caption “Executive Compensation”.

ITEM 12.     SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS.

The information regarding the security ownership of certain beneficial owners and management is incorporated by reference to the 2012 Proxy Statement under the caption “Security Ownership of Certain Beneficial Owners and Management.”

The information regarding “Securities Authorized for Issuance under Equity Compensation Plans” is incorporated by reference to our 2012 Proxy Statement under the caption “Executive Compensation — Equity Compensation Plan Information.”

ITEM 13.    CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE.

The information required by this item is incorporated by reference to the 2012 Proxy Statement under the caption “Certain Relationships and Related Transactions,” and “Management of the Company.”

 

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ITEM 14.     PRINCIPAL ACCOUNTING FEES AND SERVICES.

The information required by this item is incorporated by reference to the 2012 Proxy Statement under the caption “Independent Public Accountants — Audit Fees.”

PART IV

ITEM 15.     EXHIBITS, FINANCIAL STATEMENTS AND SCHEDULES.

 

(a)(1)       Financial Statements

The following financial statements are incorporated by reference from pages F-11 through F-36 of our Annual Report to Stockholders for the fiscal year ended December 31, 2011, as provided in Item 8 hereof:

 

Report of Independent Registered Public Accounting Firm

     F-11   

Consolidated Balance Sheets

     F-13   

Consolidated Statements of Operations

     F-14   

Consolidated Statements of Stockholders’ Equity and Comprehensive Income

     F-15   

Consolidated Statements of Cash Flows

     F-16   

Notes to Consolidated Financial Statements

     F-17   

 

(a)(2) Financial Statement Schedules — Schedule II—Valuation and Qualifying Accounts. All other schedules are omitted because of the absence of the conditions under which they are required or because the required information is included elsewhere in the financial statements.

 

(a)(3)       and (b) Exhibits — Refer below.

 

Exhibit
Number

 

Description

 

Location

    1.0     Underwriting Agreement, by and between Universal Biosensors, Inc. and Wilson HTM Corporate Finance Limited dated November 9, 2007.   Incorporated by reference to our Current Report on Form 8-K filed on November 16, 2007 as Exhibit 1.1.
    3.1     Amended and restated articles of incorporation dated December 5, 2006.   Incorporated by reference to our General Form for Registration of Securities on Form 10 filed on April 30, 2007 as Exhibit 3.1.
    3.2     Amended and restated by-laws dated December 5, 2006.   Incorporated by reference to our Amendment No. 5 to Form 10 filed on April 29, 2008 as Exhibit 3.2.
    10.1     License Agreement between LifeScan and Universal Biosensors, Inc effective April 1, 2002, as amended on October 25, 2007, December 5, 2005   Incorporated by reference to our General Form for Registration of Securities on Form 10 filed on April 30, 2007 as Exhibit 10.1. October 2007 amendment incorporated by reference to our Form 10-Q filed on November 14, 2007 as Exhibit 10.2.
    10.2     Amended and Restated License Agreement, between LifeScan, Inc. and Universal Biosensors Pty Ltd dated on August 29, 2011 and effective as of August 19, 2011   Incorporated by reference to our Current Report on Form 8-K filed on August 30, 2011 as Exhibit10.1.
    10.3     Development and Research Agreement by and between Universal Biosensors, Inc and LifeScan, Inc dated April 1, 2002 as amended on October 29, 2007, June 1, 2007, December 7, 2005, December 21, 2004 and March 31, 2004   Incorporated by reference to our General Form for Registration of Securities on Form 10 filed on April 30, 2007 as Exhibit 10.2. June 2007 amendment incorporated by reference to our Amendment No. 2 to Form 10 filed on June 12, 2007 as Exhibit 10.2. October 2007 amendment incorporated by reference to our Form 10-Q filed on November 14, 2007 as Exhibit 10.3.

 

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    10.4     Amended and Restated Development and Research Agreement between Cilag GmbH International and Universal Biosensors Pty Ltd dated on August 29, 2011 and effective as of August 19, 2011   Incorporated by reference to our Current Report on Form 8-K filed on August 30, 2011 as Exhibit 10.2.
    10.5     Form of indemnity agreement entered into with directors of us, our chief financial officer and company secretary   Incorporated by reference to our General Form for Registration of Securities on Form 10 filed on April 30, 2007 as Exhibit 10.3.
    10.6     Lease of premises 1 Corporate Avenue, Rowville Victoria Australia by and between Universal Biosensors Pty Ltd and Heyram Properties Pty Ltd.   Incorporated by reference to our General Form for Registration of Securities on Form 10 filed on April 30, 2007 as Exhibit 10.5.
    10.7     AusIndustry, R&D Start Program Agreement, effective February 25, 2005 (particular and general conditions)   Incorporated by reference to our General Form for Registration of Securities on Form 10 filed on April 30, 2007 as Exhibit 10.6.
    10.8     Employee Option Plan   Incorporated by reference to our General Form for Registration of Securities on Form 10 filed on April 30, 2007 as Exhibit 10.7
    10.9     Employment agreement between Universal Biosensors Pty Ltd and Mr. Salesh Balak effective November 27, 2006   Incorporated by reference to our General Form for Registration of Securities on Form 10 filed on April 30, 2007 as Exhibit 10.8
    10.10     Employment agreement between Universal Biosensors Pty Ltd and Mr. Garry Chambers effective April 1, 2006   Incorporated by reference to our General Form for Registration of Securities on Form 10 filed on April 30, 2007 as Exhibit 10.9
    10.11     Employment agreement between Universal Biosensors Pty Ltd and Dr Ronald Chatelier dated April 1, 2006   Incorporated by reference to our General Form for Registration of Securities on Form 10 filed on April 30, 2007 as Exhibit 10.10
    10.12     Employment agreement between Universal Biosensors Pty Ltd and Dr Alastair Hodges effective April 1, 2006   Incorporated by reference to our General Form for Registration of Securities on Form 10 filed on April 30, 2007 as Exhibit 10.11
    10.13     Employment agreement between Universal Biosensors Pty Ltd and Mr. Adrian Oates dated August 15, 2007   Incorporated by reference to our Form 10-K filed on March 16, 2010 as Exhibit 10.12
    10.14     Master Services and Supply Agreement by and between Universal Biosensors Pty Ltd, Universal Biosensors, Inc. and LifeScan, Inc. dated October 29, 2007   Incorporated by reference to our Quarterly Report on Form 10-Q filed on November 14, 2007 as Exhibit 10.1. Confidentiality treatment has been granted for portions of this exhibit. These confidential portions have been omitted and were filed separately with the SEC.
    10.15     First Amendment to the Master services and Supply Agreement dated December 11, 2008 (which amends the Master Services and Supply Agreement by and between Universal Biosensors Pty Ltd, Universal Biosensors, Inc. and LifeScan, Inc. dated October 29, 2007 and filed on November 14, 2007 as Exhibit 10.1 to our Quarterly Report on Form 10-Q)   Incorporated by reference to our Annual Report on Form 10-K filed on March 30, 2009 as Exhibit 10.14

 

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    10.16     Second Services Addendum — manufacturing Process Support (which amends the Master Services and Supply Agreement by and between Universal Biosensors Pty Ltd, Universal Biosensors, Inc. and LifeScan, Inc. dated October 29, 2007 incorporated by reference to our Quarterly Report on Form 10-Q filed on November 14, 2007 as Exhibit 10.1.)   Incorporated by reference to our Annual Report on Form 10-K filed on March 30, 2009 as Exhibit 10.15
    10.17     Advanced Care Enhanced Product Agreement (which is an addendum to the Amended and Restated Master Services and Supply Agreement filed on August 7, 2009 as Exhibit 10.3 to our Quarterly Report on Form 10-Q)   Incorporated by reference to our Quarterly Report on Form 10-Q filed on August 7, 2009 as Exhibit 10.1. Confidentiality treatment has been granted for portions of this exhibit. These confidential portions have been omitted and were filed separately with the SEC.
    10.18     Fifth Amendment to Development and Research Agreement (which amends the Development and Research Agreement by and between Universal Biosensors, Inc. and LifeScan, Inc. dated April 1, 2002 and filed on April 30, 2007 as Exhibit 10.2 to our Form 10, the Amendment to the Development and Research Agreement filed on June 12 as Exhibit 10.2 to Amendment No. 2 to our Form 10 and the Amendment to Development and Research Agreement filed on November 14, 2007 as Exhibit 10.3 to our Quarterly Report on Form 10-Q.   Incorporated by reference to our Quarterly Report on Form 10-Q filed on August 7, 2009 as Exhibit 10.2.
    10.19     Amended and Restated Master Services and Supply Agreement (which amends and restates the Master Services and Supply Agreement by and between Universal Biosensors Pty. Ltd., Universal Biosensors, Inc., and LifeScan, Inc. dated October 29, 2007 filed on November 14, 2007 as Exhibit 10.1 to our Quarterly Report on Form 10-Q and the First Amendment to the Master Services and Supply Agreement filed on March 30, 2009 as Exhibit 10.14 to our Annual Report on Form 10-K)   Incorporated by reference to our Quarterly Report on Form 10-Q filed on August 7, 2009 as Exhibit 10.3. Confidentiality treatment has been granted for portions of this exhibit. These confidential portions have been omitted and were filed separately with the SEC.
    10.20     Manufacturing Initiation Payment Addendum to Master Services and Supply Agreement (which is an addendum to the Amended and Restated Master Services and Supply Agreement filed on August 7, 2009 as Exhibit 10.3 to our Quarterly Report on Form 10-Q)   Incorporated by reference to our Quarterly Report on Form 10-Q filed on August 7, 2009 as Exhibit 10.4. Confidentiality treatment has been granted for portions of this exhibit. These confidential portions have been omitted and were filed separately with the SEC.

 

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    10.21     Employment agreement between Universal Biosensors Pty Ltd and Mr. Andrew Denver dated September 9, 2010   Incorporated by reference to our Current Report on Form 8-K/A filed on December 22, 2010 as Exhibit 10.1.
    10.22    

Collaboration Agreement between

Universal Biosensors Pty Ltd and Siemens Healthcare Diagnostics Inc. dated September 9, 2011.

  Incorporated by reference to our Quarterly Report on Form 10-Q filed on November 3, 2011 as Exhibit 10.20. Confidentiality treatment has been granted for portions of this exhibit. These confidential portions have been omitted and were filed separately with the SEC.
    10.23     Statement of Work for MAP Feasibility Project between Universal Biosensors Pty Ltd, LifeScan, Inc. and Cilag GmbH International dated October 11, 2011.   Incorporated by reference to our Quarterly Report on Form 10-Q filed on November 3, 2011 as Exhibit 10.21. Confidentiality treatment has been granted for portions of this exhibit. These confidential portions have been omitted and were filed separately with the SEC.
    10.24     Novation Agreement and First Amendment to the Amended and Restated Master Services and Supply Agreement between Universal Biosensors, Inc., Universal Biosensors Pty Ltd, LifeScan, Inc. and Cilag GmbH International dated October 11, 2011.   Incorporated by reference to our Quarterly Report on Form 10-Q filed on November 3, 2011 as Exhibit 10.22.
    10.25     Second Amendment to the Amended and Restated Master Services and Supply Agreement between Universal Biosensors, Inc., Universal Biosensors Pty Ltd, LifeScan, Inc. and Cilag GmbH International dated October 11, 2011.   Incorporated by reference to our Quarterly Report on Form 10-Q filed on November 3, 2011 as Exhibit 10.23. Confidentiality treatment has been granted for portions of this exhibit. These confidential portions have been omitted and were filed separately with the SEC.
    10.26     Employment agreement between Universal Biosensors Pty Ltd and Mr. Paul Wright effective March 1, 2011   Incorporated by reference to our Current Report on Form 8-K filed on February 25, 2011 as Exhibit 10.1.
    10.27     Employment agreement between Universal Biosensors Pty Ltd and Mr. Fred Davis effective November 2, 2011   Filed herewith
    13.0     Annual Report   Filed herewith
    14.0     Code of Ethics   Incorporated by reference to our Annual Report on Form 10-K filed on March 28, 2008 as Exhibit 14.0
    21.0     List of Subsidiaries   Incorporated by reference to our General Form for Registration of Securities on Form 10 filed on April 30, 2007 as Exhibit 21.0
    24.0     Power of Attorney   Included on signature page
    31.1     Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act   Filed herewith
    31.2     Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act   Filed herewith
    32.0     Certification of Principal Executive Officer and Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act   Filed herewith

 

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    101    

The following materials from the Universal Biosensors, Inc. Annual Report on Form 10-K for the financial year ended December 31, 2011 formatted in Extensible Business Reporting Language (XBRL): (i) the Consolidated Condensed Balance Sheets, (ii) the Consolidated Condensed Statements of Operations, (iii) the Consolidated Condensed Statements of

Changes in Stockholder’s Equity and Comprehensive Income, (iv) the Consolidated Condensed Statements of Cash Flows and (v) the Notes to Consolidated Condensed Financial Statements tagged as blocks of text

  As provided in Rule 406T of Regulation S-T, this information is furnished herewith and not filed for purposes of Sections 11 and 12 of the Securities Act of 1933 and Section 18 of the Securities Exchange Act of 1934

 

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SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this Form 10-K to be signed on its behalf by the undersigned, thereunto duly authorized.

 

   

Universal Biosensors, Inc.

(Registrant)

    By:   /s/    Paul Wright
      Paul Wright
Date: March 13, 2012       Principal Executive Officer

POWER OF ATTORNEY

Each person whose signature appears below hereby constitutes and appoints Paul Wright and Salesh Balak and each of them, his or her attorneys-in-fact, each with the power of substitution, for him or her and in his or her name, place and stead, in any and all capacities, to sign any and all amendments to this report on Form 10-K, and to file the same, with all exhibits thereto and all documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them full power and authority to do and perform each and every act and all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that such attorneys in-fact and agents or any of them or his or their substitute or substitutes, may lawfully do or cause to be done by virtue thereof.

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed by the following on behalf of the registrant and in the capacities and on the dates indicated:

 

Signature

  

Title

  

Date

/s/ Paul Wright   

Chief Executive Officer

(Principal Executive Officer)

   March 13, 2012
Paul Wright      
/s/ Salesh Balak   

Chief Financial Officer

(Principal Financial Officer)

   March 13, 2012
Salesh Balak      
/s/ Andrew Denver    Director and Chairman    March 13, 2012
Andrew Denver      
/s/ Denis Hanley    Director    March 13, 2012
Denis Hanley      
/s/ Andrew Jane    Director    March 13, 2012
Andrew Jane      
/s/ Elizabeth Wilson    Director    March 13, 2012
Elizabeth Wilson      
/s/ Colin Adam    Director    March 13, 2012
Colin Adam      
/s/ Marshall Heinberg    Director    March 13, 2012
Marshall Heinberg      

 

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INDEX TO EXHIBITS

 

Exhibit
Number

   

Description

 

Location

  1.0      Underwriting Agreement, by and between Universal Biosensors, Inc. and Wilson HTM Corporate Finance Limited dated November 9, 2007.   Incorporated by reference to our Current Report on Form 8-K filed on November 16, 2007 as Exhibit 1.1.
  3.1      Amended and restated articles of incorporation dated December 5, 2006.   Incorporated by reference to our General Form for Registration of Securities on Form 10 filed on April 30, 2007 as Exhibit 3.1.
  3.2      Amended and restated by-laws dated December 5, 2006.   Incorporated by reference to our Amendment No. 5 to Form 10 filed on April 29, 2008 as Exhibit 3.2.
  10.1      License Agreement between LifeScan and Universal Biosensors, Inc effective April 1, 2002, as amended on October 25, 2007, December 5, 2005   Incorporated by reference to our General Form for Registration of Securities on Form 10 filed on April 30, 2007 as Exhibit 10.1. October 2007 amendment incorporated by reference to our Form 10-Q filed on November 14, 2007 as Exhibit 10.2.
  10.2      Amended and Restated License Agreement, between LifeScan, Inc. and Universal Biosensors Pty Ltd dated on August 29, 2011 and effective as of August 19, 2011   Incorporated by reference to our Current Report on Form 8-K filed on August 30, 2011 as Exhibit EX-10.1.
  10.3      Development and Research Agreement by and between Universal Biosensors, Inc and LifeScan, Inc dated April 1, 2002 as amended on October 29, 2007, June 1, 2007, December 7, 2005, December 21, 2004 and March 31, 2004   Incorporated by reference to our General Form for Registration of Securities on Form 10 filed on April 30, 2007 as Exhibit 10.2. June 2007 amendment incorporated by reference to our Amendment No. 2 to Form 10 filed on June 12, 2007 as Exhibit 10.2. October 2007 amendment incorporated by reference to our Form 10-Q filed on November 14, 2007 as Exhibit 10.3.
  10.4      Amended and Restated Development and Research Agreement between Cilag GmbH International and Universal Biosensors Pty Ltd dated on August 29, 2011 and effective as of August 19, 2011   Incorporated by reference to our Current Report on Form 8-K filed on August 30, 2011 as Exhibit EX-10.2.
  10.5      Form of indemnity agreement entered into with directors of us, our chief financial officer and company secretary   Incorporated by reference to our General Form for Registration of Securities on Form 10 filed on April 30, 2007 as Exhibit 10.3.
  10.6      Lease of premises 1 Corporate Avenue, Rowville Victoria Australia by and between Universal Biosensors Pty Ltd and Heyram Properties Pty Ltd.   Incorporated by reference to our General Form for Registration of Securities on Form 10 filed on April 30, 2007 as Exhibit 10.5.
  10.7      AusIndustry, R&D Start Program Agreement, effective February 25, 2005 (particular and general conditions)   Incorporated by reference to our General Form for Registration of Securities on Form 10 filed on April 30, 2007 as Exhibit 10.6.
  10.8      Employee Option Plan   Incorporated by reference to our General Form for Registration of Securities on Form 10 filed on April 30, 2007 as Exhibit 10.7

 

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  10.9      Employment agreement between Universal Biosensors Pty Ltd and Mr. Salesh Balak effective November 27, 2006   Incorporated by reference to our General Form for Registration of Securities on Form 10 filed on April 30, 2007 as Exhibit 10.8
  10.10      Employment agreement between Universal Biosensors Pty Ltd and Mr. Garry Chambers effective April 1, 2006   Incorporated by reference to our General Form for Registration of Securities on Form 10 filed on April 30, 2007 as Exhibit 10.9
  10.11      Employment agreement between Universal Biosensors Pty Ltd and Dr Ronald Chatelier dated April 1, 2006   Incorporated by reference to our General Form for Registration of Securities on Form 10 filed on April 30, 2007 as Exhibit 10.10
  10.12      Employment agreement between Universal Biosensors Pty Ltd and Dr Alastair Hodges effective April 1, 2006   Incorporated by reference to our General Form for Registration of Securities on Form 10 filed on April 30, 2007 as Exhibit 10.11
  10.13      Employment agreement between Universal Biosensors Pty Ltd and Mr. Adrian Oates dated August 15, 2007   Incorporated by reference to our Form 10-K filed on March 16, 2010 as Exhibit 10.12
  10.14      Master Services and Supply Agreement by and between Universal Biosensors Pty Ltd, Universal Biosensors, Inc. and LifeScan, Inc. dated October 29, 2007   Incorporated by reference to our Quarterly Report on Form 10-Q filed on November 14, 2007 as Exhibit 10.1. Confidentiality treatment has been granted for portions of this exhibit. These confidential portions have been omitted and were filed separately with the SEC.
  10.15      First Amendment to the Master services and Supply Agreement dated December 11, 2008 (which amends the Master Services and Supply Agreement by and between Universal Biosensors Pty Ltd, Universal Biosensors, Inc. and LifeScan, Inc. dated October 29, 2007 and filed on November 14, 2007 as Exhibit 10.1 to our Quarterly Report on Form 10-Q)   Incorporated by reference to our Annual Report on Form 10-K filed on March 30, 2009 as Exhibit 10.14
  10.16      Second Services Addendum — manufacturing Process Support (which amends the Master Services and Supply Agreement by and between Universal Biosensors Pty Ltd, Universal Biosensors, Inc. and LifeScan, Inc. dated October 29, 2007 incorporated by reference to our Quarterly Report on Form 10-Q filed on November 14, 2007 as Exhibit 10.1.)   Incorporated by reference to our Annual Report on Form 10-K filed on March 30, 2009 as Exhibit 10.15
  10.17      Advanced Care Enhanced Product Agreement (which is an addendum to the Amended and Restated Master Services and Supply Agreement filed on August 7, 2009 as Exhibit 10.3 to our Quarterly Report on Form 10-Q)   Incorporated by reference to our Quarterly Report on Form 10-Q filed on August 7, 2009 as Exhibit 10.1. Confidentiality treatment has been granted for portions of this exhibit. These confidential portions have been omitted and were filed separately with the SEC.

 

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  10.18      Fifth Amendment to Development and Research Agreement (which amends the Development and Research Agreement by and between Universal Biosensors, Inc. and LifeScan, Inc. dated April 1, 2002 and filed on April 30, 2007 as Exhibit 10.2 to our Form 10, the Amendment to the Development and Research Agreement filed on June 12 as Exhibit 10.2 to Amendment No. 2 to our Form 10 and the Amendment to Development and Research Agreement filed on November 14, 2007 as Exhibit 10.3 to our Quarterly Report on Form 10-Q.   Incorporated by reference to our Quarterly Report on Form 10-Q filed on August 7, 2009 as Exhibit 10.2.
  10.19      Amended and Restated Master Services and Supply Agreement (which amends and restates the Master Services and Supply Agreement by and between Universal Biosensors Pty. Ltd., Universal Biosensors, Inc., and LifeScan, Inc. dated October 29, 2007 filed on November 14, 2007 as Exhibit 10.1 to our Quarterly Report on Form 10-Q and the First Amendment to the Master Services and Supply Agreement filed on March 30, 2009 as Exhibit 10.14 to our Annual Report on Form 10-K)   Incorporated by reference to our Quarterly Report on Form 10-Q filed on August 7, 2009 as Exhibit 10.3. Confidentiality treatment has been granted for portions of this exhibit. These confidential portions have been omitted and were filed separately with the SEC.
  10.20      Manufacturing Initiation Payment Addendum to Master Services and Supply Agreement (which is an addendum to the Amended and Restated Master Services and Supply Agreement filed on August 7, 2009 as Exhibit 10.3 to our Quarterly Report on Form 10-Q)   Incorporated by reference to our Quarterly Report on Form 10-Q filed on August 7, 2009 as Exhibit 10.4. Confidentiality treatment has been granted for portions of this exhibit. These confidential portions have been omitted and were filed separately with the SEC.
  10.21      Employment agreement between Universal Biosensors Pty Ltd and Mr. Andrew Denver dated September 9, 2010   Incorporated by reference to our Current Report on Form 8-K/A filed on December 22, 2010 as Exhibit 10.1.
  10.22     

Collaboration Agreement between

Universal Biosensors Pty Ltd and Siemens Healthcare Diagnostics Inc. dated September 9, 2011.

  Incorporated by reference to our Quarterly Report on Form 10-Q filed on November 3, 2011 as Exhibit 10.20. Confidentiality treatment has been granted for portions of this exhibit. These confidential portions have been omitted and were filed separately with the SEC.
  10.23      Statement of Work for MAP Feasibility Project between Universal Biosensors Pty Ltd, LifeScan, Inc. and Cilag GmbH International dated October 11, 2011.   Incorporated by reference to our Quarterly Report on Form 10-Q filed on November 3, 2011 as Exhibit 10.21. Confidentiality treatment has been granted for portions of this exhibit. These confidential portions have been omitted and were filed separately with the SEC.

 

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  10.24      Novation Agreement and First Amendment to the Amended and Restated Master Services and Supply Agreement between Universal Biosensors, Inc., Universal Biosensors Pty Ltd, LifeScan, Inc. and Cilag GmbH International dated October 11, 2011.   Incorporated by reference to our Quarterly Report on Form 10-Q filed on November 3, 2011 as Exhibit 10.22.
  10.25      Second Amendment to the Amended and Restated Master Services and Supply Agreement between Universal Biosensors, Inc., Universal Biosensors Pty Ltd, LifeScan, Inc. and Cilag GmbH International dated October 11, 2011.  

Incorporated by reference to our Quarterly Report on Form 10-Q filed on November 3, 2011 as Exhibit 10.23. Confidentiality treatment has been granted for portions of this exhibit. These confidential portions have been omitted and were filed separately with the SEC.

  10.26      Employment agreement between Universal Biosensors Pty Ltd and Mr. Paul Wright effective March 1, 2011   Incorporated by reference to our Current Report on Form 8-K filed on February 25, 2011 as Exhibit 10.1.
  10.27      Employment agreement between Universal Biosensors Pty Ltd and Mr. Fred Davis effective November 2, 2011   Filed herewith
  13.0      Annual Report   Filed herewith
  14.0      Code of Ethics   Incorporated by reference to our Annual Report on Form 10-K filed on March 28, 2008 as Exhibit 14.0
  21.0      List of Subsidiaries   Incorporated by reference to our General Form for Registration of Securities on Form 10 filed on April 30, 2007 as Exhibit 21.0
  24.0      Power of Attorney   Included on signature page
  31.1      Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act   Filed herewith
  31.2      Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act   Filed herewith
  32.0      Certification of Principal Executive Officer and Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act   Filed herewith
  101      The following materials from the Universal Biosensors, Inc. Annual Report on Form 10-K for the financial year ended December 31, 2011 formatted in Extensible Business Reporting Language (XBRL): (i) the Consolidated Condensed Balance Sheets, (ii) the Consolidated Condensed Statements of Operations, (iii) the Consolidated Condensed Statements of Changes in Stockholder’s Equity and Comprehensive Income, (iv) the Consolidated Condensed Statements of Cash Flows and (v) the Notes to Consolidated Condensed Financial Statements tagged as blocks of text   As provided in Rule 406T of Regulation S-T, this information is furnished herewith and not filed for purposes of Sections 11 and 12 of the Securities Act of 1933 and Section 18 of the Securities Exchange Act of 1934

 

41

EX-10.27 2 d266783dex1027.htm EMPLOYMENT AGREEMENT Employment Agreement

Exhibit 10.27

Universal Biosensors Pty Ltd

ABN 35 098 234 309

1 Corporate Avenue

Rowville Victoria 3178

Australia

Telephone +61 3 9212 9000

Facsimile +61 3 9212 9099

Email info@universalbiosensors.com

www.universalbiosensors.com

 

LOGO

20th September 2011

Fred Davis

9 Dryden Street

Canterbury Victoria 3126

Dear Fred,

Letter of Offer and Terms of Employment

Universal Biosensors Pty Ltd ACN 098 234 309 (Company)

It is with great pleasure that the Company offers you employment on the following terms and conditions.

 

1.1 Your terms and conditions of employment are set out in this letter. Your employment is also covered by applicable laws and employment standards.

 

1.2 You are being employed as VP Business Development. Your primary duties will be those set out in the attached position description and such other duties as the Company may request from time to time. Your supervisor will be the CEO. In performing this or any other position, you agree to:

 

  (a) observe all rules, regulations, directions and policies of the Company;

 

  (b) perform your duties in a diligent and professional manner and to the best of your ability;

 

  (c) follow such reasonable directions and perform such duties as the Company may give to you;

 

  (d) perform your duties in a manner that complies with all applicable laws and regulations; and


Universal Biosensors Pty Ltd

ABN 35 098 234 309

1 Corporate Avenue

Rowville Victoria 3178

Australia

Telephone +61 3 9212 9000

Facsimile +61 3 9212 9099

Email info@universalbiosensors.com

www.universalbiosensors.com

 

LOGO

 

  (e) not without the written consent of the Company engage in any activity, whether paid or unpaid, which could, in the Company’s opinion, conflict with your duties or with the business interests of the Company.

 

1.3 Your position description, reporting lines and location of work may change from time to time. In the event of any such change the terms of this agreement will continue to apply to your employment, unless varied, replaced or superseded in writing.

 

2. Hours of work

This is a full-time position. You will be expected to work not less than 38 hours per week. Regular business hours for the Company are currently 8:30 am to 5:30 pm Monday to Friday. You will from time to time be required to work reasonable additional hours in order to perform your duties effectively and otherwise as may reasonably be required by the Company. You acknowledge that the remuneration specified in this letter is sufficient to cover payment for all additional hours and that no overtime payments will be payable.

 

3. Commencement date and term

Your employment will commence on 2nd November 2011 and is terminable as set out in this letter.

The first 3 months of your employment will be on probation. During this period, you or the Company may terminate your employment by giving one week’s written notice to the other party or the payment or forfeiture as the case may be of one week’s salary.

 

4. Location

Your employment will be based at the Company’s office in Melbourne. You may be required to travel to other places from time to time to carry out your duties.

 

5. Remuneration

 

5.1 Your salary is $270,000 per annum plus superannuation which is currently 9% of base salary.

 

5.2 The remuneration provided under this agreement has been set specifically having regard to any and all entitlements that may apply now, or in the future, under an award, workplace agreement or similar instrument, including shift penalties and allowances (howsoever described).


Universal Biosensors Pty Ltd

ABN 35 098 234 309

1 Corporate Avenue

Rowville Victoria 3178

Australia

Telephone +61 3 9212 9000

Facsimile +61 3 9212 9099

Email info@universalbiosensors.com

www.universalbiosensors.com

 

LOGO

 

5.3 If an award, workplace agreement or similar instrument applies to the employment, then:

 

  (a) your remuneration is in satisfaction of all minimum award, workplace agreement or similar entitlements including minimum wage, overtime, allowances, penalties, extra rates for working evenings weekends or Public Holidays, payment for temporarily working in a more senior role and annual leave loading;

 

  (b) if there are any changes to the entitlements in paragraph (a), then your remuneration is applied to and absorbs those changed entitlements; and

 

  (c) the Company may vary your remuneration to incorporate the value of an entitlement (although will not reduce it).

 

5.4 Your salary will be paid two weeks in advance and two weeks in arrears in 12 equal calendar monthly instalments on or about the 15th day of the month (or other usual payment date for employees) and deposited into a bank account nominated by you.

 

5.5 Payment of your superannuation entitlements will be in accordance with applicable legislation and the Company’s policies from time to time.

 

5.6 During your employment there will be ongoing review of your performance. Your base remuneration may be reviewed annually by the Company. Any increase in your remuneration is at the sole discretion of the Company.

 

5.7 You will be awarded a performance related bonus of up to 20% of your annual salary (proportionally reduced in the first year to reflect the amount of time worked) subject to you meeting an agreed set of key performance indicators. The key performance indicators will be determined by the Remuneration and Nomination Committee annual and agreed with you. The achievement of those key performance indicators will be determined by the Remuneration and Nomination Committee annually. You must be a continuing employee of the Company at the time the bonus is considered and paid in order to be eligible.

 

5.8 175,000 options over fully paid ordinary shares exercisable at the prevailing market price at the time of Board approval of grant. The options will vest over three years based on continued employment. Any shares issued on exercise of the options will be restricted from sale for 4 years from the date of grant of the options, following which, ongoing Board approval may be required with respect to the sale of shares.


Universal Biosensors Pty Ltd

ABN 35 098 234 309

1 Corporate Avenue

Rowville Victoria 3178

Australia

Telephone +61 3 9212 9000

Facsimile +61 3 9212 9099

Email info@universalbiosensors.com

www.universalbiosensors.com

 

LOGO

 

5.9 You will be provided with a mobile phone and laptop to be used for business purposes in accordance with Company policy.

 

6. Leave entitlements

 

6.1 You are entitled to leave (e.g. annual leave, personal leave, carers leave, compassionate leave, parental leave, community service leave and long service leave) in accordance with the National Employment Standards. A summary of your entitlements to leave is contained in the Fair Work Information Statement located in your employee folder, or can be accessed electronically at www.fwa.gov.au.

 

6.2 Annual leave must ordinarily be taken at times which do not conflict with the Company’s operational requirements. The Company will endeavour to accommodate your preference for the time at which leave is taken. However generally no more than two weeks’ leave will be taken at any one time unless by mutual consent. You may be directed to take annual leave during shut down periods.

 

6.3 You will be entitled to public holidays as proclaimed in Victoria without loss of pay.

 

7. Confidentiality

 

7.1 During and after your employment, you must keep confidential and not disclose to any person any information which you obtain in the course of your employment and which is not available to the public, other than in a manner expressly authorized by the Company. Such information would include: all commercial information about the Company, all commercial information about the business, financial plans, strategy, sales and marketing information, production techniques, technical information, trade secrets, know-how and other processes.

 

7.2 During and after your employment, you must not use any information which you obtain in the course of your employment and which is not available to the public other than in the performance of your duties and for the benefit of the Company or otherwise in a manner expressly authorized by the Company.

 

7.3 You must:

 

  (a) only use the information obtained by you in the course of your employment with the Company for the benefit or advantage of the Company and for no other purpose;


Universal Biosensors Pty Ltd

ABN 35 098 234 309

1 Corporate Avenue

Rowville Victoria 3178

Australia

Telephone +61 3 9212 9000

Facsimile +61 3 9212 9099

Email info@universalbiosensors.com

www.universalbiosensors.com

 

LOGO

 

  (b) strictly adhere to the Company’s policies in relation to the treatment of confidential information;

 

  (c) comply with any security measures established by the Company and safeguard the confidential information from unauthorised access or use;

 

  (d) immediately notify the Company of any suspected or actual unauthorised use, copying or disclosure of the information, of which you become aware;

 

  (e) upon request by the Company and upon termination, return to the Company all records, documents, computer disks, papers, notes (including copies) and everything else in your possession or control which contains or records information of the Company and not retain any copies of such information in any form; and

 

  (f) during and after your employment, provide assistance reasonably requested by the Company in relation to any proceedings it may take against any person for unauthorised use, copying or disclosure of the information.

 

7.4 Your obligations of confidentiality do not extend to information that is public knowledge (otherwise than as a result of a breach of confidence by any person) or is required by law to be disclosed.

 

8. Intellectual Property

 

8.1 You must promptly, fully and effectively disclose to the Company or its nominee either in writing, orally or both (as required by the Company) full details of any intellectual property or industrial property generated or conceived by you during your employment (whether or not during business hours and whether or not before or after the execution of a formal employment agreement), relating to or connected with any of the matters which have been, are or may become subject of Company’s business affairs or business and whether or not capable of statutory protection, including without limitation each and every invention (whether patentable or not), process, know-how, formula design (whether registrable or not), trademark or service mark and any copyright material, trade secret or other confidential information (“Company Intellectual Property”).


Universal Biosensors Pty Ltd

ABN 35 098 234 309

1 Corporate Avenue

Rowville Victoria 3178

Australia

Telephone +61 3 9212 9000

Facsimile +61 3 9212 9099

Email info@universalbiosensors.com

www.universalbiosensors.com

 

LOGO

 

8.2 In exchange for the benefits conferred on you by your employment, you:

 

  (a) agree that by virtue of this provision, to the extent permitted by law, all Company Intellectual Property is the property of the Company or its nominee and vests in the Company immediately upon creation;

 

  (b) consent to all acts or omissions by the Company in relation to your moral rights in all copyright works in such Company Intellectual Property; and

 

  (c) consent to the infringement of your moral rights in all copyright works in such Company Intellectual Property by the Company, its licensees, assignees and successors in title and any person authorised by the Company at the absolute discretion of the Company and without reference to you.

 

8.3 You must at the request and expense of the Company without additional compensation from the Company, sign all such documents (including assignment deeds) and do all such things as may be necessary to vest, confirm and perfect and record ownership by the Company or its nominee throughout the world of the right, title and interest to and in the Company Intellectual Property and to enable the Company or its nominee to acquire and preserve such rights and to have the full enjoyment of such intellectual property.

 

8.4 You must keep complete written records of everything you invent or develop. These records belong to the Company and must be at all times retained in your custody and control at the Company’s premises and must be handed to the Company on demand.

 

9. Records

 

9.1 The Company owns all documents and records (in any form) relating to the business of the Company, whether or not prepared by you. On demand by the Company and in any event at the end of your employment, you must:

 

  (a) deliver to the Company all those documents and records in the your possession or control; and then

 

  (b) delete all those documents and records held electronically in any medium in your possession or control.

 

9.2 During and after your employment, you must use and permit to be used those documents and records for the Company’s benefit only.


Universal Biosensors Pty Ltd

ABN 35 098 234 309

1 Corporate Avenue

Rowville Victoria 3178

Australia

Telephone +61 3 9212 9000

Facsimile +61 3 9212 9099

Email info@universalbiosensors.com

www.universalbiosensors.com

 

LOGO

 

10. Restraint

 

10.1 You must not during your employment participate, promote, carry on, assist or otherwise be concerned or interested financially or otherwise, in any capacity (including as principal, agent, partner, employee, shareholder, unitholder, director, trustee, beneficiary, financier, consultant or adviser) in any business or activity which is the same as, or substantially similar to the business of the Company or its associates, unless the Company otherwise agrees in writing;

 

10.2 You must not during your employment and or a period of 3 months after termination of your employment, directly or indirectly, on your own account or on behalf of any person or entity, anywhere in which the Company or its associates carries on business:

 

  (a) solicit, canvass, induce or encourage any employee or agent of the Company or its associates to leave the employment or agency of the Company or such associates;

 

  (b) solicit, canvass, approach any customer of the Company or its associates with a view to soliciting the business of that customer; or

 

  (c) interfere or seek to interfere with the relationship between the Company or its associates (on the one hand) and the customers, suppliers and employees of the Company or its associates (on the other hand).

 

10.3 You acknowledge the prohibitions and restrictions contained in this clause are reasonable in the circumstances and necessary to protect the Company and its associate’s businesses.

 

10.4 Each of the obligations imposed on you under this clause is a separate and independent obligation from the other restraint obligations imposed, but they are cumulative in effect. If any separate provision is unenforceable, illegal or void, that provision is severed and the other separate provisions remain in force.

 

10.5 You acknowledge and agree that each of the restraints imposed upon you under this clause 10 are fair and reasonable and are no greater than is reasonably necessary to protect the Company.

 

11. Termination

 

11.1 During the probation period of three months, either party may terminate your employment in accordance with clause 3 of this letter.


Universal Biosensors Pty Ltd

ABN 35 098 234 309

1 Corporate Avenue

Rowville Victoria 3178

Australia

Telephone +61 3 9212 9000

Facsimile +61 3 9212 9099

Email info@universalbiosensors.com

www.universalbiosensors.com

 

LOGO

 

11.2 The Company or you may at any time terminate your employment by giving 3 month’s written notice. The Company may choose to make payment in lieu of notice, or require you to work some of the notice period and pay you in lieu of working for the balance of the notice period. You agree this is a reasonable period of notice for termination without cause.

 

11.3 You are entitled to an additional week’s notice if you are over 45 years old and have completed at least 2 years of continuous service with the employer on the day the notice of termination is given.

 

11.4 During the notice period, you may be required to perform duties other than your normal duties or to not attend the workplace for all or part of the notice period

 

11.5 The Company may at any time terminate your employment without notice for cause, including if:

 

  (a) you commit any serious or persistent breach of your employment obligations.

 

  (b) you fail to comply with any reasonable directions of the Company;

 

  (c) you are guilty of any serious misconduct or wilful neglect in performing your duties;

 

  (d) you engage in fraudulent conduct;

 

  (e) in the reasonable opinion of the persons to whom you report, you are guilty of any dishonesty relating to the affairs of the Company

 

  (f) you are negligent in the performance of your duties;

 

  (g) you work under the influence of drugs or alcohol;

 

  (h) you commit a serious or persistent breach of Company policy;

 

  (i) you are found guilty of an indictable offence; or

 

  (j) you bring the Company into disrepute.

 

11.6 Termination of your employment does not affect in any way your obligations under clauses 7 to 10 of this letter.


Universal Biosensors Pty Ltd

ABN 35 098 234 309

1 Corporate Avenue

Rowville Victoria 3178

Australia

Telephone +61 3 9212 9000

Facsimile +61 3 9212 9099

Email info@universalbiosensors.com

www.universalbiosensors.com

 

LOGO

 

11.7 When your employment ends, you must return to the Company all of the Company’s property in your possession or control.

 

12. Special Conditions

 

12.1 The following special conditions (if any) will apply to your employment with the Company. In the event of any inconsistency between other terms of this letter and this clause, the special conditions will prevail to the extent of any such inconsistency.

Further professional training allowance of up to a maximum of $15,000 per annum or 2 weeks training to be approved by the CEO.

 

13. General

 

13.1

This offer lapses if you do not sign and return the documentation to me by 3rd October 2011.

 

13.2 The terms of employment set out in this document will continue to apply except to the extent that they are varied, replaced or cancelled by agreement in writing signed by both parties.

 

13.3 The failure of the Company at any time to insist on performance of any provision of the terms of employment set out in this document is not a waiver of its right at any later time to insist on performance of that or any other provision of this letter.

 

13.4 This letter sets out the entire understanding and agreement between the parties with respect to the terms and conditions of the employment offered with the Company.

 

13.5 The interpretation of the agreement constituted by your acceptance of this offer is governed by the laws of Victoria.

I look forward to welcoming you as a member of our team. It would be appreciated if you would accept this offer by signing the enclosed copy of this letter and returning it to me by the date set out in 13.1 above.


Universal Biosensors Pty Ltd

ABN 35 098 234 309

1 Corporate Avenue

Rowville Victoria 3178

Australia

Telephone +61 3 9212 9000

Facsimile +61 3 9212 9099

Email info@universalbiosensors.com

www.universalbiosensors.com

 

LOGO

Yours faithfully,

Paul Wright

Chief Executive Officer

ACCEPTANCE

I accept this offer:

 

Signed:  

 

    Dated:  
  Fred Davis      
EX-13.0 3 d266783dex130.htm ANNUAL REPORT Annual Report

Exhibit 13

Universal Biosensors, Inc.

2011 Annual Report

Contents

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

     F-2   

Report of Independent Registered Public Accounting Firm

     F-11   

Consolidated Balance Sheets

     F-13   

Consolidated Statements of Operations

     F-14   

Consolidated Statements of Stockholders’ Equity and Comprehensive Income

     F-15   

Consolidated Statements of Cash Flows

     F-16   

Notes to Consolidated Financial Statements

     F-17   

Schedule ii — Valuation and Qualifying Accounts

     F-36   

 

F-1


Management’s Discussion and Analysis of Financial Condition and Results of Operations

Universal Biosensors, Inc.

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our financial statements and related notes that appear elsewhere in this Annual Report. In addition to historical financial information, the following discussion contains forward-looking statements that reflect our plans, estimates and beliefs. Our actual results may differ materially from those discussed in the forward-looking statements in our Form 10-K. Factors that could cause or contribute to these differences include those discussed below and elsewhere in our Form 10-K, particularly in “Risk Factors.”

Our Business

We are a specialist medical diagnostics company focused on the research, development and manufacture of in vitro diagnostic test devices for consumer and professional point-of-care use.

We were incorporated in the State of Delaware on September 14, 2001 and our shares of common stock in the form of CHESS Depositary Interests (“CDIs”) have been quoted on the Australian Securities Exchange (“ASX”) since December 13, 2006. Our securities are not currently traded on any other public market. Our wholly owned subsidiary and primary operating vehicle, Universal Biosensors Pty Ltd (“UBS”) was incorporated as a proprietary limited company in Australia on September 21, 2001. UBS conducts our research, development and manufacturing activities in Melbourne, Australia.

We have rights to an extensive patent portfolio, with certain patents owned by UBS and a number licensed to UBS under a license agreement between LifeScan, Inc. (“LifeScan”) and UBS (“License Agreement”). Unless otherwise noted, references to “LifeScan” in this document are references collectively or individually to LifeScan, Inc., and/or LifeScan Europe, a division of Cilag GmbH International, both affiliates of Johnson and Johnson.

We are using our electrochemical cell technology platform to develop tests for a number of different markets. Our current focus is as set out below:

 

  Ÿ  

Blood glucose — UBS provides services and acts as a non-exclusive manufacturer of test strips for LifeScan’s “OneTouch® VerioTM”, pursuant to a Master Services and Supply Agreement with LifeScan (“Master Services and Supply Agreement”). LifeScan continues its global rollout of the OneTouch Verio product which is currently available in North America, major European markets and Australia. We also undertake research and development work for LifeScan pursuant to a development and research agreement (“Development and Research Agreement”).

 

  Ÿ  

Coagulation testing market — UBS is working with Siemens Healthcare Diagnostics, Inc. (“Siemens”) to develop a range of test strips and reader products for the point-of-care coagulation market, pursuant to a collaboration agreement (“Collaboration Agreement”).

 

  Ÿ  

Other electrochemical-cell based tests — we are working on proving the broader applicability of our technology platform for other immunoassay and molecular diagnostic point-of-care tests. We may seek to enter into collaborative arrangements or strategic alliances with respect to any tests arising from this work.

Results of Operations

Revenue from Products

OneTouch® VerioTM was first launched in the Netherlands in January 2010 and has subsequently been launched in Australia, in major European markets and North America. The manufacturing results of the blood glucose test strips during the respective periods are as follows:

 

     Years Ended December 31,  
     2011     2010     2009  
     A$     A$     A$  

Revenue from products

     12,063,582        11,760,009        132,733   

Cost of goods sold

     (12,310,302     (10,801,062     (458,162
  

 

 

   

 

 

   

 

 

 
     (246,720     958,947        (325,429
  

 

 

   

 

 

   

 

 

 

 

F-2


Management’s Discussion and Analysis of Financial Condition and Results of Operations

Universal Biosensors, Inc.

 

Pursuant to the agreement we have with LifeScan, one of two pricing methodologies will apply depending on whether we are manufacturing above or below a specified quantity of blood glucose test strips in a quarter. If less than the specified quantity of test strips is produced within a quarter, we are considered to be in the “interim costing period”. In the interim costing period, the Company is not expected to generate any profit from the manufacture of test strips, but is expected to recover most of its glucose manufacturing costs. If manufactured volumes increase beyond the specified quantity of blood glucose test strips per quarter, the interim costing period will cease to apply and a different pricing methodology will apply, at which time we expect our blood glucose manufacturing operations to be profitable. We commenced commercial production in 2009 and operated under the interim costing period regime during that year. During 2010 and 2011, we ceased to be in the interim costing period during the fourth quarter of each of 2010 and 2011 at which time we generated profits from our blood glucose manufacturing operations. Our quarterly results from our blood glucose manufacturing operations for the 2011 and 2010 financial year reflect this.

 

     2011 Quarter Ended  
     December 31     September 30     June 30     March 31  
     A$     A$     A$     A$  

Revenue from products

     4,322,897        2,153,518        2,267,766        3,319,401   

Cost of goods sold

     (3,809,376     (2,314,082     (2,694,792     (3,492,052
  

 

 

   

 

 

   

 

 

   

 

 

 
     513,521        (160,564     (427,026     (172,651
  

 

 

   

 

 

   

 

 

   

 

 

 
     2010 Quarter Ended  
     December 31     September 30     June 30     March 31  
     A$     A$     A$     A$  

Revenue from products

     5,672,739        3,202,873        1,359,584        1,524,813   

Cost of goods sold

     (4,189,520     (3,136,390     (1,936,716     (1,538,436
  

 

 

   

 

 

   

 

 

   

 

 

 
     1,483,219        66,483        (577,132     (13,623
  

 

 

   

 

 

   

 

 

   

 

 

 

During 2009, LifeScan chose not to proceed with the registration of the then current product but to proceed with an enhanced product, called One-Touch Verio, and acknowledged that there would be a delay as a result. As a result of this change, LifeScan agreed to pay us an additional amount per strip manufactured by us up to a certain volume in 2010. In 2011, as long as we remained in the interim costing period, LifeScan agreed to pay us an additional amount per strip equivalent to 50% of the amount agreed with LifeScan in 2010. These additional payments ceased during the third quarter of 2011 resulting in the higher margin in the last quarter of 2010 when compared to the same period in 2011 and the small profit in the third quarter of 2010.

Revenue from Services

We provide various services to our customers and partners. The revenue is grouped into the following categories:

 

  Ÿ  

Contract research and development — we undertake contract research and development on behalf of our customers and partners. Contract research and development revenue up to the 2009 financial year has been recorded under the caption “Research and development income”. As we commenced commercial production in 2010, the research and development was seen more as a service we provide which meant presenting it within “Revenue from Services”;

 

  Ÿ  

Product enhancement — a service fee based on the number of strips sold by our customers and partners is payable to us as an ongoing reward for our services and efforts to enhance the product;

 

  Ÿ  

Other services — ad-hoc services provided on an agreed basis based on our customers and partners requirements.

 

F-3


Management’s Discussion and Analysis of Financial Condition and Results of Operations

Universal Biosensors, Inc.

 

There are different arrangements for each service being provided. The net margin during the respective periods in relation to the provision of services is as follows:

 

     Years Ended December 31,  
     2011     2010     2009  
     A$     A$     A$  

Revenue from services

     2,632,870        6,420,027        2,850,071   

Cost of services

     (708,149     (1,481,674     (169,241
  

 

 

   

 

 

   

 

 

 
     1,924,721        4,938,353        2,680,830   

Income — Research and development income

                   1,337,125   

Contract research and development makes up the major portion of revenue from services. The nature and scope of contract research and development is determined by our customers and partners based upon their requirements hence our revenues and margins tend to fluctuate. This is reflected in our past three years results wherein the margin during the 2011 financial year has decreased by 61% compared to the 2010 financial year while the margin during the 2010 financial year has increased by 23% compared to the 2009 financial year. In September 2011, we commenced a new research and development project for LifeScan to determine the feasibility of an innovative blood glucose product. The feasibility project is expected to take 12 months. Revenue is recognized for the feasibility project when services have been performed, the amount of the payment can be reliably measured and collectability is reasonably assured. We recognize revenue for accounting purposes ratably over the feasibility period.

We received a non-refundable payment of US$3 million in September 2011 upon entering into a collaboration agreement with Siemens. This deliverable is not a separate unit of accounting and has been recorded as deferred revenue and will be recognized as revenue across the deliverables in the arrangement with Siemens.

Milestone Payment

We received a milestone payment of A$17,722,641 in 2009 triggered by the first grant to LifeScan of regulatory clearance to sell the blood glucose test.

Research and Development Expenses

Research and development expenses are related to developing electrochemical cell platform technologies. Research and development expenses consist of costs associated with research activities, as well as costs associated with our product development efforts, including pilot manufacturing costs. Research and development expenses include:

 

  Ÿ  

consultant and employee related expenses, which include consulting fees, salary and benefits;

 

  Ÿ  

materials and consumables acquired for the research and development activities;

 

  Ÿ  

external research and development expenses incurred under agreements with third party organizations and universities; and

 

  Ÿ  

facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities, depreciation of leasehold improvements and equipment and laboratory and other supplies.

Our principal research and development activities can be described as follows:

(a)  Blood coagulation

Since 2005, we have undertaken development work on a prothrombin time test for monitoring the therapeutic range of the anticoagulant, warfarin, based on measuring activity of the enzyme thrombin. In

 

F-4


Management’s Discussion and Analysis of Financial Condition and Results of Operations

Universal Biosensors, Inc.

 

September 2011 we entered into a collaboration agreement with Siemens pursuant to which will develop a range of test strips and reader products for the point-of-care coagulation market. The first test to be developed will be a modified version of a Prothrombin Time International Normalized Ratio (“PT-INR”) test developed by UBS, followed by other tests in the point-of-care coagulation market.

(b)  Immunoassay

We are continuing to develop our immunoassay platform. We are developing a D-dimer test for the detection and monitoring of several conditions associated with thrombotic disease, particularly deep venous thrombosis (clots in the leg) and pulmonary embolism (clots in the lung). Development work on this project has been undertaken since early 2008.

This work will allow the electrochemical cell platform technology to be expanded to a range of immunoassay tests.

(c)  DNA/RNA

We have undertaken some early stage feasibility work assessing the possibility of using DNA binding chemistries to build a strip test for DNA, RNA and as a possible alternative method for improving the sensitivity of protein assays. This concept work is at an early stage and may not yield any positive results. We have recently entered into a license to access certain molecular diagnostic technology.

Research and development expenses for the respective periods are as follows:

 

     Years Ended December 31,  
     2011      2010      2009  
     A$      A$      A$  

Research and development expenses

     9,812,396         6,482,150         14,898,072   
  

 

 

    

 

 

    

 

 

 

Depending on the number of research and development activities we undertake and the development phase of the research and development, our research and development expenditure will fluctuate. Research and development expenditure increased by 51% during 2011 compared to 2010 and decreased by 56% during 2010 compared to 2009. Research and development expenses for 2009 reflect the conclusion of the development phase for the blood glucose product, wherein a significant amount of the work was carried out. All costs pertaining to this project after January 2010 are now captured in cost of goods sold as opposed to being treated as a research and development expenditure as they were prior to January 2010. During 2010 and 2011, our research and development activities were primarily focussed around the blood coagulation platform. Whilst we had established feasibility of the first product on this platform, the prothrombin time test, in 2010, we were at an advanced stage in 2011. During 2011 we had entered the formal development and validation stage of the prothrombin time test. An increased volume of work is required during this development phase of a research and development. During the latter half of 2011, we also commenced work on a range of other test strips and reader products for the point-of-care coagulation market pursuant to our agreement with Siemens.

While we have a degree of control as to how much we spend on research and development activities in the future, we cannot predict what it will cost to complete our individual research and development programs successfully or when or if they will be commercialized. The timing and cost of any program is dependent upon achieving technical objectives, which are inherently uncertain.

In addition, our business strategy contemplates that we may enter into collaborative arrangements with third parties for one or more of our non-blood glucose programs. In the event that we are successful in securing such third party collaborative arrangements, the third party will direct the research and development activities which will influence our research and development expenditure and these parties may contribute towards all or part of the cost of these activities.

 

F-5


Management’s Discussion and Analysis of Financial Condition and Results of Operations

Universal Biosensors, Inc.

 

General and Administrative Expenses

General and administrative expenses currently consist principally of salaries and related costs, including stock option expense, for personnel in executive, business development, finance, accounting, information technology and human resources functions. Other general and administrative expenses include depreciation, repairs and maintenance, insurance, facility costs not otherwise included in research and development expenses, consultancy fees and professional fees for legal, audit and accounting services.

General and administrative expenses for the respective periods are as follows:

 

     Years Ended December 31,  
     2011      2010      2009  
     A$      A$      A$  

General and administrative expenses

     7,271,488         7,185,550         5,635,569   
  

 

 

    

 

 

    

 

 

 

General and administrative expenses increased by 1% during 2011 compared to 2010 and increased by 28% during 2010 compared to 2009. This increase in expenses, particularly during 2010, reflects efforts put into business development to establish collaborative partnerships in the fields outside the area of glucose and diabetes. 2010 was also the first financial year wherein our auditors had to undertake internal controls work in order to furnish an attestation report regarding internal controls over financial reporting as required under the Sarbanes Oxley Act. This resulted in us incurring additional expenditure.

Interest Income

Interest income decreased to A$683,323 in 2011 from A$1,192,889 in 2010. The decrease in interest income is attributable to the lower amounts of funds available for investment. Interest income increased to A$1,192,889 in 2010 from A$809,459 in 2009. The increase in interest income is attributable to increased returns on the funds invested and the higher amounts of funds available for investment.

Critical Accounting Estimates and Judgments

Our consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The preparation of these consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, income, costs and expenses, and related disclosures. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates.

We believe that of our significant accounting policies, which are described in the notes to our consolidated financial statements, the following accounting policies involve a greater degree of judgment and complexity. Accordingly, we believe that the following accounting policies are the most critical to aid in fully understanding and evaluating our consolidated financial condition and results of operations.

(a)  Revenue Recognition

The Company recognizes revenue when persuasive evidence of an arrangement exists, delivery has occurred, the sales price is fixed or determinable, and collection is probable. Product is considered delivered to the customer once it has been shipped and title and risk of loss have been transferred.

In addition, the Company enters into arrangements, which contain multiple revenue generating activities. The revenue for these arrangements is recognized as each activity is performed or delivered, based on the relative fair value and the allocation of revenue to all deliverables based on their relative selling price. In such circumstances, the Company uses a hierarchy to determine the selling price to be used for allocation of revenue to deliverables, vendor-specific objective evidence, third-party evidence of selling price and best estimate of selling price. The Company’s process for determining its best estimate of selling price for deliverables without

 

F-6


Management’s Discussion and Analysis of Financial Condition and Results of Operations

Universal Biosensors, Inc.

 

vendor-specific objective evidence or third-party evidence of selling price involves management’s judgment. The Company’s process considers multiple factors that may vary depending upon the unique facts and circumstances related to each deliverable.

(b)  Stock-Based Compensation

We account for stock-based employee compensation arrangements using the modified prospective method as prescribed in accordance with the provisions of ASC 718 – Compensation – Stock Compensation.

Each of the inputs to the Trinomial Lattice model is discussed below.

Share Price at Valuation Date

The value of the options granted in 2010 and 2011 has been determined using the closing price of our common stock trading in the form of CDIs on ASX at the time of grant of the options. The value of the options granted in 2009 have been determined using the average closing price of the Company’s common stock on the ASX on the five days on which the Company’s common stock has traded prior to the approval of grant. The ASX is the only exchange upon which our securities are quoted.

Volatility

We applied volatility having regard to the historical price change of our shares in the form of CDIs available from the ASX.

Time to Expiry

All options granted under our share option plan have a maximum 10 year term and are non-transferable.

Risk Free Rate

The risk free rate which we applied is equivalent to the yield on an Australian government bond with a time to expiry approximately equal to the expected time to expiry on the options being valued.

(c)  Income Taxes

We apply ASC 740 — Income Taxes which establishes financial accounting and reporting standards for the effects of income taxes that result from a company’s activities during the current and preceding years. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carry forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.

Where it is more likely than not that some portion or all of the deferred tax assets will not be realized the deferred tax assets are reduced by a valuation allowance. The valuation allowance is sufficient to reduce the deferred tax assets to the amount that is more likely than not to be realized.

(d)  Impairment of Long-Lived Assets

We review our capital assets, including patents and licenses, for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. In performing the review, we estimate undiscounted cash flows from products under development that are covered by these patents and licenses. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of the asset and its eventual disposition is less than the carrying amount of the asset. If the evaluation indicates that the carrying value of an asset is not recoverable from its undiscounted cash flows, an impairment loss is measured by comparing the carrying value of the asset to its fair value, based on discounted cash flows.

 

F-7


Management’s Discussion and Analysis of Financial Condition and Results of Operations

Universal Biosensors, Inc.

 

Financial Condition, Liquidity and Capital Resources

Net Financial Assets

Our net financial assets position is shown below:

 

     Years Ended December 31,  
     2011      2010      2009  
     A$      A$      A$  

Financial assets:

        

Cash and cash equivalents

     15,089,209         23,271,766         31,291,011   

Accounts receivables

     4,889,783         3,588,798         415,397   

Financial instruments

     83,339                   
  

 

 

    

 

 

    

 

 

 

Total financial assets

     20,062,331         26,860,564         31,706,408   
  

 

 

    

 

 

    

 

 

 

Debt:

        

Short and long term debt/borrowings

                       

Financial instruments

                     47,412   
  

 

 

    

 

 

    

 

 

 

Total debt

                     47,412   
  

 

 

    

 

 

    

 

 

 

Net financial assets

     20,062,331         26,860,564         31,658,996   
  

 

 

    

 

 

    

 

 

 

We rely largely on our existing cash and cash equivalents and funds from our operations to provide for the working capital needs of our operations. We believe we have sufficient cash and cash equivalents to fund our operations for at least the next twelve months.

Measures of Liquidity and Capital Resources

The following table provides certain relevant measures of liquidity and capital resources:

 

     Years Ended December 31,  
     2011      2010      2009  
     A$      A$      A$  

Cash and cash equivalents

     15,089,209         23,271,766         31,291,011   

Working capital

     17,584,523         25,940,899         32,118,842   

Ratio of current assets to current liabilities

     3.51 : 1         6.82 : 1         13.05 : 1   

Shareholders’ equity per common share

     0.22         0.30         0.33   

The movement in cash and cash equivalents and working capital in each of the years was primarily due to the timing of cash receipts, payments, sales and accruals in the ordinary course of business. 2009 was also impacted by the receipt of a milestone payment of A$17,722,641. We have not identified any collection issues with respect to receivables.

Summary of Cash Flows

 

     Years Ended December 31,  
     2011     2010     2009  
     A$     A$     A$  

Cash provided by/(used in):

      

Operating activities

     (7,159,118     (6,414,248     5,867,156   

Investing activities

     (1,102,943     (2,320,293     (2,990,007

Financing activities

     79,504        715,296        78,998   
  

 

 

   

 

 

   

 

 

 

Net increase/(decrease) in cash and cash equivalents

     (8,182,557     (8,019,245     2,956,147   
  

 

 

   

 

 

   

 

 

 

 

F-8


Management’s Discussion and Analysis of Financial Condition and Results of Operations

Universal Biosensors, Inc.

 

Our net cash used in operating activities in 2011 and 2010 was primarily for our research and development projects including efforts involved in establishing our manufacturing. The outflows during these two years have been partially offset by receipts from our customers and partners. The positive operating activity result in 2009 is predominantly as a result of the receipt of the milestone payment of A$17,722,641 in December 2009.

Our net cash used in investing activities for all years is primarily for the purchase of various plant and equipment and fit out of our facilities based on our needs.

Our net cash provided by financing activities is primarily proceeds received from employees exercising their options.

Off-Balance Sheet Arrangement

The future minimum lease payments under non-cancellable operating leases (with initial or remaining lease terms in excess of one year) as of December 31, 2011 are:

 

     A$  

Less than 1 year

     556,082   

1 — 3 years

     714,244   

3 — 5 years

       

More than 5 years

       
  

 

 

 

Total minimum lease payments

     1,270,326   
  

 

 

 

The above relates to our operating lease obligations in relation to the lease of our premises and certain office equipment.

Contractual Obligations

Our future contractual obligations at December 31, 2011 were as follows:

 

     Payments Due By Period  
     Total      Less than 1      1 – 3 years      3 – 5 years      More than 5  
     A$      A$      A$      A$      A$  

Asset Retirement Obligations(1)

     2,166,691                         2,166,691           

Operating Lease Obligations(2)

     1,270,326         556,082         714,244                   

Purchase Obligations(3)

     3,173,761         1,773,761         1,400,000                   

Other Long-Term Liabilities on

              

Balance Sheet(4)

     181,367                 119,237         55,860         6,270   
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total

     6,792,145         2,329,843         2,233,481         2,222,551         6,270   
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

 

(1) Represents legal obligations associated with the retirement and removal of long-lived assets.

 

(2) Our operating lease obligations relate primarily to the lease of our premises.

 

(3) Represents outstanding purchase orders and contractual obligations that are payable on the achievement of certain milestones

 

(4) Represents long service leave owing to the employees.

Segments

We operate in one segment. Our principal activities are research and development, commercial manufacture of approved medical or testing devices and the provision of services including contract research work. We operate predominantly in one geographical area, being Australia.

 

F-9


Management’s Discussion and Analysis of Financial Condition and Results of Operations

Universal Biosensors, Inc.

 

Recent Accounting Pronouncements

See Notes to Consolidated Financial Statements – Note 2. Summary of Significant Accounting Policies.

Financial Risk Management

The overall objective of our financial risk management program is to seek to minimize the impact of foreign exchange rate movements and interest rate movements on our earnings. We manage these financial exposures through operational means and by using financial instruments. These practices may change as economic conditions change.

Foreign Currency Market Risk

We transact business in various foreign currencies, including U.S. dollars and Euros. We have established a foreign currency hedging program using forward contracts to hedge the net projected exposure for each currency and the anticipated sales and purchases in U.S. dollars and Euros. The goal of this hedging program is to economically guarantee or lock-in the exchange rates on our foreign exchange exposures. The Company does not hold or issue derivative financial instruments for trading purposes. However, derivatives that do not qualify for hedge accounting are accounted for as trading instruments.

The following table sets out the notional amounts and weighted average exchange rates by expected (contractual) maturity dates. These notional amounts generally are used to calculate the contractual payments to be exchanged under the contract.

 

     2012 (*)    Fair Value  

Anticipated Transactions and Related Derivatives

     

AUD Functional Currency:

     

Forward exchange agreements (Sell USD/Buy AUD)

     

Contract amount

   US$4,000,000    A$ 4,114,179   

Average contractual exchange rate

   0.9923   

*  Expected maturity or transaction date

Interest Rate Risk

Since the majority of our investments are in cash and cash equivalents in AUD, our exposure to interest income is affected by changes in the general level of Australian interest rates. The primary objective of our investment activities is to preserve principal while at the same time maximizing the income we receive without significantly increasing risk. Our investment portfolio is subject to interest rate risk but due to the short duration of our investment portfolio, we believe an immediate 10% change in interest rates would not be material to our financial condition or results of operations.

Inflation

Our business is subject to the general risks of inflation. Our results of operations depend on our ability to anticipate and react to changes in the price of raw materials and other related costs over which we may have little control. Our inability to anticipate and respond effectively to an adverse change in the price could have a significant adverse effect on our results of operations. In the face of increasing costs, the Company strives to maintain its profit margins through cost reduction programs, productivity improvements and periodic price increases.

 

F-10


LOGO

 

Report of Independent Registered Public Accounting Firm

To the Board of Directors and Shareholders of Universal Biosensors, Inc.

In our opinion, the accompanying consolidated balance sheets and the related consolidated statements of operations, consolidated statements of stockholders’ equity and comprehensive income and consolidated statements of cash flows present fairly, in all material respects, the financial position of Universal Biosensors, Inc. and its subsidiaries at December 31, 2011 and December 31, 2010, and the results of their operations and their cash flows for each of the three years in the period ended December 31, 2011 in conformity with accounting principles generally accepted in the United States of America. In addition, in our opinion, the financial statement schedule listed in the appendix under Item 15(a)(2) present fairly, in all material respects, the information set forth therein when read in conjunction with the related consolidated financial statements. Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2011, based on criteria established in Internal Control — Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). The Company’s management is responsible for these financial statements and financial statement schedule, for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in Management’s Report on Internal Control over Financial Reporting appearing under Item 9A. Our responsibility is to express opinions on these financial statements, on the financial statement schedule, and on the Company’s internal control over financial reporting based on our audits (which were integrated audits in 2011 and 2010). We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement and whether effective internal control over financial reporting was maintained in all material respects. Our audits of the financial statements included examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and evaluating the overall financial statement presentation. Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audits also included performing such other procedures as we considered necessary in the circumstances. We believe that our audits provide a reasonable basis for our opinions.

A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.

 

F-11

    PricewaterhouseCoopers, ABN 52 780 433 757

    Darling Park Tower 2, 201 Sussex Street, GPO BOX 2650, SYDNEY NSW 1171, DX 77 Sydney

    T: +61 2 8266 0000, F: +61 2 8266 9999, www.pwc.com.au


LOGO

 

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

 

/s/    PricewaterhouseCoopers
PricewaterhouseCoopers

Sydney

March 13, 2012

 

F-12

    PricewaterhouseCoopers, ABN 52 780 433 757

    Darling Park Tower 2, 201 Sussex Street, GPO BOX 2650, SYDNEY NSW 1171, DX 77 Sydney

    T: +61 2 8266 0000, F: +61 2 8266 9999, www.pwc.com.au


Universal Biosensors, Inc.

Consolidated Balance Sheets

 

     December 31,
2011
    December 31,
2010
 
     A$     A$  

ASSETS

  

Current assets:

    

Cash and cash equivalents

     15,089,209        23,271,766   

Inventories, net

     3,619,400        3,191,093   

Accounts receivable

     4,889,783        3,588,798   

Prepayments

     92,048        303,181   

Financial instruments

     83,339          

Other current assets

     827,508        46,196   
  

 

 

   

 

 

 

Total current assets

     24,601,287        30,401,034   

Non-current assets:

    

Property, plant and equipment

     33,151,027        32,713,280   

Less accumulated depreciation

     (12,855,847     (9,586,365
  

 

 

   

 

 

 

Property, plant and equipment — net

     20,295,180        23,126,915   
  

 

 

   

 

 

 

Other non-current assets

     320,000        310,000   
  

 

 

   

 

 

 

Total non-current assets

     20,615,180        23,436,915   
  

 

 

   

 

 

 

Total assets

     45,216,467        53,837,949   
  

 

 

   

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

  

Current liabilities:

    

Accounts payable

     620,682        1,764,364   

Accrued expenses

     2,061,528        2,099,477   

Deferred revenue

     3,509,721          

Employee entitlements provision

     824,833        596,294   
  

 

 

   

 

 

 

Total current liabilities

     7,016,764        4,460,135   

Non-current liabilities:

    

Asset retirement obligations

     2,166,691        1,998,060   

Employee entitlements provision

     181,367        160,675   

Deferred revenue

     829,039          
  

 

 

   

 

 

 

Total non-current liabilities

     3,177,097        2,158,735   
  

 

 

   

 

 

 

Total liabilities

     10,193,861        6,618,870   
  

 

 

   

 

 

 

Commitments and contingencies (Note 3)

              
  

 

 

   

 

 

 

Stockholders’ equity:

    

Preferred stock, $0.01 par value. Authorized 1,000,000 shares;issued and outstanding nil in 2011 (2010: nil)

    

Common stock, $0.0001 par value. Authorized 300,000,000 shares; issued and outstanding 159,139,965 shares in 2011 (2010: 158,871,495)

     15,914        15,887   

Additional paid-in capital

     79,446,995        77,034,717   

Accumulated deficit

     (29,533,213     (22,922,688

Current year loss

     (14,692,117     (6,610,525

Accumulated other comprehensive income

     (214,973     (298,312
  

 

 

   

 

 

 

Total stockholders’ equity

     35,022,606        47,219,079   
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

     45,216,467        53,837,949   
  

 

 

   

 

 

 

See accompanying notes to the financial statements

 

F-13


Universal Biosensors, Inc.

Consolidated Statements of Operations

 

     Years Ended December 31,  
     2011     2010     2009  
     A$     A$     A$  

Revenue

      

Revenue from products

   $ 12,063,582      $ 11,760,009      $ 132,733   

Revenue from services

     2,632,870        6,420,027        2,850,071   

Research and development income

                   1,337,125   

Milestone payment

                   17,722,641   
  

 

 

   

 

 

   

 

 

 

Total revenue

     14,696,452        18,180,036        22,042,570   

Operating costs & expenses

      

Cost of goods sold

     12,310,302        10,801,062        458,162   

Cost of services

     708,149        1,481,674        169,241   

Research and development

     9,812,396        6,482,150        14,898,072   

General and administrative

     7,271,488        7,185,550        5,635,569   
  

 

 

   

 

 

   

 

 

 

Total operating costs & expenses

     30,102,335        25,950,436        21,161,044   
  

 

 

   

 

 

   

 

 

 

Profit/(loss) from operations

     (15,405,883     (7,770,400     881,526   

Other income/(expense)

      

Interest income

     683,323        1,192,889        809,459   

Interest expense

                   (9,636

Other

     30,443        (33,014     (250,886
  

 

 

   

 

 

   

 

 

 

Total other income/(expense)

     713,766        1,159,875        548,937   

Net profit/(loss) before tax

     (14,692,117     (6,610,525     1,430,463   

Income tax benefit/(expense)

                     
  

 

 

   

 

 

   

 

 

 

Net profit/(loss)

   $ (14,692,117   $ (6,610,525   $ 1,430,463   
  

 

 

   

 

 

   

 

 

 

Basic net profit/(loss) per share

   $ (0.09   $ (0.04   $ 0.01   

Average weighted number of shares — basic

     159,017,777        157,584,044        157,013,578   

Diluted net profit/(loss) per share

   $ (0.09   $ (0.04   $ 0.01   

Average weighted number of shares — diluted

     159,017,777        157,584,044        161,354,802   

See accompanying notes to the financial statements.

 

F-14


Universal Biosensors, Inc.

Consolidated Statements of Stockholders’ Equity and Comprehensive Income

 

     Ordinary shares      Additional
Paid-in

Capital
     Accumulated
Deficit
    Other
Comprehensive
Income
    Total
Stockholders’

Equity
 
     Shares      Amount            
            A$      A$      A$     A$     A$  

Balances at January 1, 2009

     156,976,936         15,698         73,338,995         (24,353,151     (298,312     48,703,230   

Comprehensive Income

               

Unrealised loss on derivatives and hedges

                                    (47,412     (47,412

Net profit

                             1,430,463               1,430,463   
               

 

 

 

Total Comprehensive income

                  1,383,051   
               

 

 

 

Exercise of stock options issued to employees

     138,327         14         78,984                       78,998   

Shares issued to employees

     40,670         4         69,948                       69,952   

Stock option expense

                     1,078,771                       1,078,771   
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Balances at December 31, 2009

     157,155,933         15,716         74,566,698         (22,922,688     (345,724     51,314,002   

Comprehensive income

               

Unrealised gain on derivatives and hedges

                                    47,412        47,412   

Net loss

                             (6,610,525            (6,610,525
               

 

 

 

Total Comprehensive income

                  (6,563,113
               

 

 

 

Exercise of stock options issued to employees

     1,667,581         167         715,129                       715,296   

Shares issued to employees

     47,981         4         75,887                       75,891   

Stock option expense

                     1,677,003                       1,677,003   
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Balances at December 31, 2010

     158,871,495         15,887         77,034,717         (29,533,213     (298,312     47,219,079   

Comprehensive income

               

Unrealised gain on derivatives and hedges

                                    83,339        83,339   

Net loss

                             (14,692,117            (14,692,117
               

 

 

 

Total Comprehensive income

                  (14,608,778
               

 

 

 

Exercise of stock options issued to employees

     181,999         18         79,486                       79,504   

Shares issued to employees

     86,471         9         76,950                       76,959   

Stock option expense

                     2,255,842                       2,255,842   
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Balances at December 31, 2011

     159,139,965         15,914         79,446,995         (44,225,330     (214,973     35,022,606   
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

See accompanying notes to the financial statements.

 

F-15


Universal Biosensors, Inc.

Consolidated Statements of Cash Flows

 

     Years Ended December 31,  
     2011     2010     2009  
     A$     A$     A$  

Cash flows from operating activities provided by/(used in):

      

Net profit/(loss)

     (14,692,117     (6,610,525     1,430,463   

Adjustments to reconcile net profit/(loss) to net cash provided by/(used in) operating activities:

      

Depreciation and amortization

     3,298,541        2,990,858        2,851,285   

Share based payments expense

     2,255,842        1,677,003        1,078,771   

Loss on fixed assets disposal

     17,715        2,618        60,658   

Change in assets and liabilities:

      

Inventory

     (428,307     (2,885,969     (305,124

Accounts receivables

     (1,300,985     (3,733,332     (114,713

Prepaid expenses and other current assets

     (725,797     (6,079     141,331   

Deferred revenue

     4,492,426        118,305        290,904   

Employee entitlements

     249,231        73,493        50,192   

Accounts payable and accrued expenses

     (325,667     1,959,380        383,389   
  

 

 

   

 

 

   

 

 

 

Net cash provided by/(used in) operating activities

     (7,159,118     (6,414,248     5,867,156   
  

 

 

   

 

 

   

 

 

 

Cash flows from investing activities:

      

Instalment payments to acquire plant and equipment

            (988,334     (2,145,808

Purchases of property, plant and equipment

     (1,102,943     (1,331,959     (844,199
  

 

 

   

 

 

   

 

 

 

Net cash used in investing activities

     (1,102,943     (2,320,293     (2,990,007
  

 

 

   

 

 

   

 

 

 

Cash flows from financing activities:

      

Proceeds from borrowings

                   479,673   

Repayment of borrowings

                   (479,673

Proceeds from stock options exercised

     79,504        715,296        78,998   
  

 

 

   

 

 

   

 

 

 

Net cash provided by financing activities

     79,504        715,296        78,998   
  

 

 

   

 

 

   

 

 

 

Net increase/(decrease) in cash and cash equivalents

     (8,182,557     (8,019,245     2,956,147   

Cash and cash equivalent at beginning of period

     23,271,766        31,291,011        28,334,864   
  

 

 

   

 

 

   

 

 

 

Cash and cash equivalents at end of period

     15,089,209        23,271,766        31,291,011   
  

 

 

   

 

 

   

 

 

 

See accompanying notes to the financial statement

 

F-16


Universal Biosensors, Inc.

Notes to Consolidated Financial Statements

(for the years ended December 31, 2009, 2010 and 2011)

 

(1)  Basis of Presentation

These consolidated financial statements are presented in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). All amounts are expressed in Australian dollars (“AUD” or “A$”) unless otherwise stated.

The Company’s consolidated financial statements have been prepared assuming the Company will continue as a going concern. We rely largely on our existing cash and cash equivalents balance and operating cash flow to provide for the working capital needs of our operations. We believe we have sufficient cash and cash equivalents to fund our operations for at least the next twelve months. However, in the event, our financing needs for the foreseeable future are not able to be met by our existing cash and cash equivalents balance and operating cash flow, we would seek to raise funds through public or private equity offerings, debt financings, and through other means to meet the financing requirements. There is no assurance that funding would be available at acceptable terms, if at all.

During 2010, the Group (consisting of Universal Biosensors, Inc. and its wholly owned subsidiary, Universal Biosensors Pty Ltd) ceased to be a development stage enterprise as it has established its commercial scale manufacturing and is generating revenue from its manufacturing operations.

 

(2)  Summary of Significant Accounting Policies

Principles of Consolidation

The consolidated financial statements include the financial statements of the Company and its wholly owned subsidiary UBS. All intercompany balances and transactions have been eliminated on consolidation.

Use of Estimates

The preparation of the consolidated financial statements requires management of the Company to make a number of estimates and assumptions relating to the reported amount of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the period. Significant items subject to such estimates and assumptions include the carrying amount of property, plant and equipment, deferred income taxes, asset retirement obligations and obligations related to employee benefits. Actual results could differ from those estimates.

Reclassification

Certain prior year amounts have been reclassified to conform to the current year presentation.

Cash & Cash Equivalents

The Company considers all highly liquid investments purchased with an initial maturity of three months or less to be cash equivalents. For cash and cash equivalents, the carrying amount approximates fair value due to the short maturity of those instruments.

Short-Term Investments (Held-to-maturity)

Short-term investments constitute all highly liquid investments with term to maturity from three months to twelve months. The carrying amount of short-term investments is equivalent to its fair value.

Concentration of Credit Risk and Other Risks and Uncertainties

Cash and cash equivalents and accounts receivables consists of financial instruments that potentially subject the Company to concentration of credit risk to the extent of the amount recorded on the balance sheet. The Company’s cash and cash equivalents are invested with two of Australia’s four largest banks. The Company is exposed to credit risk in the event of default by the banks holding the cash or cash equivalents to the extent of the

 

F-17


Universal Biosensors, Inc.

Notes to Consolidated Financial Statements

(for the years ended December 31, 2009, 2010 and 2011)

 

amount recorded on the balance sheets. The Company has not experienced any losses on its deposits of cash and cash equivalents. The Company has not identified any collectability issues with respect to receivables.

Derivative Instruments and Hedging Activities

Derivative financial instruments

The Company uses derivative financial instruments to hedge its exposure to foreign exchange arising from operating, investing and financing activities. The Company does not hold or issue derivative financial instruments for trading purposes. However, derivatives that do not qualify for hedge accounting are accounted for as trading instruments.

Derivative financial instruments are recognized initially at fair value. Subsequent to initial recognition, derivative financial instruments are stated at fair value. The gain or loss on remeasurement to fair value is recognized immediately in the income statement. However, where derivatives qualify for hedge accounting, recognition of any resultant gain or loss depends on the nature of the item being hedged.

Cash flow hedges

Exposure to foreign exchange risks arises in the normal course of the Company’s business and it is the Company’s policy to use forward exchange contracts to hedge anticipated sales and purchases in foreign currencies. The amount of forward cover taken is in accordance with approved policy and internal forecasts.

Where a derivative financial instrument is designated as a hedge of the variability in cash flows of a recognized asset or liability, or a highly probable forecast transaction, the effective part of any unrealised gain or loss on the derivative financial instrument is recognized directly in equity. When the forecast transaction subsequently results in the recognition of a non-financial asset or non-financial liability, the associated cumulative gain or loss is removed from equity and included in the initial cost or other carrying amount of the non-financial asset or liability.

For cash flow hedges, other than those covered by the preceding statement, the associated cumulative gain or loss is removed from equity and recognized in the consolidated statements of operations in the same period or periods during which the hedged forecast transaction affects the consolidated statements of operations and on the same line item as that hedged forecast transaction. The ineffective part of any gain or loss is recognized immediately in the consolidated statements of operations.

When a hedging instrument expires or is sold, terminated or exercised, or the Company revokes designation of the hedge relationship but the hedged forecast transaction is still probable to occur, the cumulative gain or loss at that point remains in equity and is recognized in accordance with the above policy when the transaction occurs. If the hedged transaction is no longer expected to take place, then the cumulative unrealized gain or loss recognized in equity is recognized immediately in the consolidated statements of operations.

Inventory

Inventories are stated at the lower of cost or net realizable value. Net realizable value is the estimated selling price in the ordinary course of business less the estimated costs of completion and estimated costs necessary to dispose. Inventories are principally determined under the average cost method which approximates cost. Cost comprises direct materials, direct labour and an appropriate portion of variable and fixed overhead expenditure, the latter being allocated on the basis of normal operating capacity. Cost also includes the transfer from equity of

 

F-18


Universal Biosensors, Inc.

Notes to Consolidated Financial Statements

(for the years ended December 31, 2009, 2010 and 2011)

 

any gains/losses on qualifying cash flow hedges relating to purchases of raw material. Costs of purchased inventory are determined after deducting rebates and discounts.

 

     Years Ended December 31,  
     2011      2010      2009  
     A$      A$      A$  

Raw materials

     3,254,675         2,798,045         289,069   

Work in progress

     102,239         188,629         16,055   

Finished goods

     262,486         204,419           
  

 

 

    

 

 

    

 

 

 
     3,619,400         3,191,093         305,124   
  

 

 

    

 

 

    

 

 

 

Receivables

Trade accounts receivable are recorded at the invoiced amount and do not bear interest. The allowance for doubtful accounts is the best estimate of the amount of probable credit losses in the existing accounts receivable. The allowance is determined based on a review of individual accounts for collectibility, generally focusing on those accounts that are past due. The current year expense to adjust the allowance for doubtful accounts, if any, is recorded within general and administrative expenses in the consolidated statements of operations. Account balances are charged against the allowance when it is probable the receivable will not be recovered.

 

     Years Ended December 31,  
     2011      2010      2009  
     A$      A$      A$  

Accounts receivable

     4,889,783         3,588,798         415,397   

Allowance for doubtful debts

                       
  

 

 

    

 

 

    

 

 

 
     4,889,783         3,588,798         415,397   
  

 

 

    

 

 

    

 

 

 

Property, Plant, and Equipment

Property, plant, and equipment are recorded at acquisition cost, less accumulated depreciation.

Depreciation on plant and equipment is calculated using the straight-line method over the estimated useful lives of the assets. The estimated useful life of machinery and equipment is 3 to 10 years. Leasehold improvements are amortized on the straight-line method over the shorter of the remaining lease term or estimated useful life of the asset. Maintenance and repairs are charged to operations as incurred and include normal services and does not include items of a capital nature.

The Company receives Victorian government grant monies under grant agreements to support our development activities, including in connection with the purchase of plant and equipment. Plant and equipment is presented net of the government grant. The grant monies are recognized against the acquisition costs of the related plant and equipment as and when the related assets are purchased.

Research and Development

Research and development expenses consist of costs incurred to further the Group’s research and development activities and include salaries and related employee benefits, costs associated with clinical trial and preclinical development, regulatory activities, research-related overhead expenses, costs associated with the manufacture of clinical trial material, costs associated with developing a commercial manufacturing process, costs for consultants and related contract research, facility costs and depreciation. Research and development costs are expensed as incurred.

 

F-19


Universal Biosensors, Inc.

Notes to Consolidated Financial Statements

(for the years ended December 31, 2009, 2010 and 2011)

 

Research and development expenses for years ended December 31, 2011, 2010 and 2009 are as follows:

 

     Years Ended December 31,  
     2011      2010      2009  
     A$      A$      A$  

Research and development expenses

     9,812,396         6,482,150         14,898,072   
  

 

 

    

 

 

    

 

 

 

Income Taxes

The Company applies ASC 740 — Income Taxes which establishes financial accounting and reporting standards for the effects of income taxes that result from a company’s activities during the current and preceding years. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carry forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.

Where it is more likely than not that some portion or all of the deferred tax assets will not be realized the deferred tax assets are reduced by a valuation allowance. The valuation allowance is sufficient to reduce the deferred tax assets to the amount that is more likely than not to be realized. A reconciliation of the valuation and qualifying accounts is attached as Schedule ii.

We are subject to income taxes in the United States and Australia. U.S. federal income tax returns up to the 2010 financial year have been filed. Internationally, consolidated income tax returns up to the 2010 financial year have been filed.

Asset Retirement Obligations

Asset retirement obligations (“ARO”) are legal obligations associated with the retirement and removal of long-lived assets. ASC 410 – Asset Retirement and Environmental Obligations requires entities to record the fair value of a liability for an asset retirement obligation when it is incurred. When the liability is initially recorded, the Company capitalizes the cost by increasing the carrying amounts of the related property, plant and equipment. Over time, the liability increases for the change in its present value, while the capitalized cost depreciates over the useful life of the asset. The Company derecognizes ARO liabilities when the related obligations are settled.

The ARO is in relation to our premises where in accordance with the terms of the lease, the lessee has to restore part of the building upon vacating the premises.

Our overall ARO changed as follows:

 

     Years Ended December 31,  
     2011      2010  
     A$      A$  

Opening balance at January 1

     1,998,060         1,842,547   

Accretion expense

     168,631         155,513   
  

 

 

    

 

 

 

Ending balance at December 31

     2,166,691         1,998,060   
  

 

 

    

 

 

 

Fair Value of Financial Instruments

The carrying value of all current assets and current liabilities approximates fair value because of their short-term nature. The estimated fair value of all other amounts has been determined, depending on the nature and complexity of the assets or the liability, by using one or all of the following approaches:

 

  Ÿ  

Market approach — based on market prices and other information from market transactions involving identical or comparable assets or liabilities.

 

F-20


Universal Biosensors, Inc.

Notes to Consolidated Financial Statements

(for the years ended December 31, 2009, 2010 and 2011)

 

  Ÿ  

Cost approach — based on the cost to acquire or construct comparable assets less an allowance for functional and/or economic obsolescence.

 

  Ÿ  

Income approach — based on the present value of a future stream of net cash flows

These fair value methodologies depend on the following types of inputs:

 

  Ÿ  

Quoted prices for identical assets or liabilities in active markets (Level 1 inputs)

 

  Ÿ  

Quoted prices for similar assets or liabilities in active markets or quoted prices for identical or similar assets or liabilities in markets that are not active or are directly or indirectly observable (Level 2 inputs)

 

  Ÿ  

Unobservable inputs that reflect estimates and assumptions (Level 3 inputs)

Impairment of Long-Lived Assets

The Company reviews its capital assets, including patents and licenses, for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. In performing the review, the Company estimates undiscounted cash flows from products under development that are covered by these patents and licenses. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of the asset and its eventual disposition is less than the carrying amount of the asset. If the evaluation indicates that the carrying value of an asset is not recoverable from its undiscounted cash flows, an impairment loss is measured by comparing the carrying value of the asset to its fair value, based on discounted cash flows.

Australian Goods and Services Tax (GST)

Revenues, expenses and assets are recognized net of the amount of associated GST, unless the GST incurred is not recoverable from the taxation authority. In this case it is recognized as part of the cost of acquisition of the asset or as part of the expense. Receivables and payables are stated inclusive of the amount of GST receivable or payable. The net amount of GST recoverable from, or payable to, the taxation authority is included with other receivables or payables in the balance sheet.

Revenue Recognition

We recognize revenue from all sources based on the provisions of the U.S. SEC’s Staff Accounting Bulletin No. 104 and ASC 605 Revenue Recognition.

The Company’s revenue represents revenue from sales of products, provision of services and collaborative research and development agreements.

We recognize revenue from sales of products at the time title of goods passes to the buyer and the buyer assumes the risks and rewards of ownership, assuming all other revenue recognition criteria have been met. Generally, this is at the time products are shipped to the customer.

Revenue from services are recognized when a persuasive evidence of an arrangement exists, services have been rendered, the price is fixed or determinable, and collectability is reasonably assured. Revenue recognition principles are assessed for each new contractual arrangement and the appropriate accounting is determined for each service.

Where our agreements contain multiple elements, or deliverables, such as the manufacture and sale of products, provision of services or research and development activities, they are assessed to determine whether separate delivery of the individual elements of such arrangements comprises more than one unit of accounting. Where an arrangement can be divided into separate units of accounting (each unit constituting a separate earnings process), the arrangement consideration is allocated amongst those varying units based on the relative selling

 

F-21


Universal Biosensors, Inc.

Notes to Consolidated Financial Statements

(for the years ended December 31, 2009, 2010 and 2011)

 

price of the separate units of accounting and the applicable revenue recognition criteria applied to the separate units. Selling prices are determined using fair value, either vendor specific objective evidence or third party evidence of the selling price, when available, or the Company’s best estimate of selling price when fair value is not available for a given unit of accounting.

Under ASC 605-25, which the Company adopted on January 1, 2009, the delivered item(s) are separate units of accounting, provided (i) the delivered item(s) have value to a customer on a stand-alone basis, and (ii) if the arrangement includes a general right of return relative to the delivered item, delivery or performance of the undelivered item(s) is considered probable and substantially in our control. Where the arrangement cannot be divided into separate units, the individual deliverables are combined as a single unit of accounting and the total arrangement consideration is recognized across other deliverables in the arrangement or over the estimated collaboration period. Payments under these arrangements typically include one or more of the following: non-refundable, upfront payments; funding of research and/or development efforts; and milestone payments.

We typically generate milestone payments from our customers pursuant to the various agreements we have with them. Non-refundable milestone payments which represent the achievement of a significant technical/regulatory hurdle in the research and development process, pursuant to collaborative agreements, and are deemed to be substantive, are recognized as revenue upon the achievement of the specified milestone If the non-refundable milestone payment is not substantive or stand-alone value, the non-refundable milestone payment is deferred and recognized as revenue either over the estimated performance period stipulated in the agreement or across other deliverables in the arrangement.

Management has concluded that the core operations of the Company are expected to be the research and development activities, commercial manufacture of approved medical or testing devices and the provision of services. The Company’s ultimate goal is to utilize the underlying technology and skill base for the development of a marketable product that the Company will manufacture. The Company considers revenue from the sales of products, revenue from services and the income received from milestone payments indicative of its core operating activities or revenue producing goals of the Company, and as such have accounted for this income as “revenues”.

Product and Service Agreements

In October 2007, the Company and LifeScan entered into a Master Services and Supply Agreement, under which the Company would provide certain services to LifeScan in the field of blood glucose monitoring and act as a non-exclusive manufacturer of blood glucose test strips. The Master Services and Supply Agreement was subsequently amended and restated in May 2009. The Company has concluded the Master Services and Supply Agreement should be accounted for as three separate units of accounting: 1) research and development to assist LifeScan in receiving regulatory clearance to sell the blood glucose product (milestone payment), 2) contract manufacturing of the blood glucose test strips (contract manufacturing) and 3) ongoing services and efforts to enhance the product (product enhancement).

All consideration within the Master Services and Supply agreement is contingent. The Company concluded the undelivered items were not priced at a significant incremental discount to the delivered items and revenue for each deliverable will be recognized as each contingency is met and the consideration becomes fixed and determinable. The milestone payment was considered to be a substantive payment and the entire amount has been recognized as revenue when the regulatory approval was received. Revenues for contract manufacturing and ongoing efforts to enhance the product are recognised as revenue from products or revenue from services, respectively, when the four basic criteria for revenue recognition are met.

In October 2011, the Company entered into a Statement of Work agreement with LifeScan to provide services for a feasibility study for an innovative blood glucose product. The services relating to this agreement are expected to take 12 months to complete which commenced in September 2011.

 

F-22


Universal Biosensors, Inc.

Notes to Consolidated Financial Statements

(for the years ended December 31, 2009, 2010 and 2011)

 

Research and Development Agreement

On September 9, 2011 the Company entered into a new collaboration agreement with Siemens to develop coagulation related products for hospital point-of-care and ambulatory care coagulation markets. In addition to an up-front, non-refundable payment of US$3 million; the Company may receive up to six payments from Siemens upon the achievement of certain defined milestones relating to feasibility, regulatory submissions and the launch of the products to be developed. The Company has concluded that the up-front payment is not a separate unit of accounting and recorded the amount as deferred revenue to be recognized as revenue across other deliverables in the arrangement with Siemens based upon the Company’s best estimate of selling price. The deliverables related to each milestone are considered substantive and are not priced at a significant incremental discount to the other deliverables. As the achievement of the milestones is contingent upon a future event, the revenue for each deliverable will be recognized as the contingencies are met and the consideration becomes fixed and determinable.

Interest income

Interest income is recognized as it accrues, taking into account the effective yield on the cash and cash equivalents.

Foreign Currency

Functional and reporting currency

Items included in the financial statements of each of the Group’s entities are measured using the currency of the primary economic environment in which the entity operates (“the functional currency”). The functional currency of the Company and UBS is AUD or A$ for all years presented.

The consolidated financial statements are presented using a reporting currency of Australian dollars.

Transactions and balances

Foreign currency transactions are translated into the functional currency using the exchange rates prevailing at the dates of the transactions. Foreign exchange gains and losses resulting from the settlement of such transactions and from the translation at year-end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognized in the consolidated statements of operations.

The Company has recorded foreign currency transaction losses of A$4,442, A$512,474 and A$250,886 in each of the years ended December 31, 2011, 2010 and 2009, respectively.

The results and financial position of all the Group entities that have a functional currency different from the reporting currency are translated into the reporting currency as follows:

 

  Ÿ  

assets and liabilities for each balance sheet item reported are translated at the closing rate at the date of that balance sheet;

 

  Ÿ  

income and expenses for each income statement are translated at average exchange rates (unless this is not a reasonable approximation of the effect of the rates prevailing on the transaction dates, in which case income and expenses are translated at the dates of the transactions); and

 

  Ÿ  

all resulting exchange differences are recognized as a separate component of equity.

On consolidation, exchange differences arising from the translation of any net investment in foreign entities are taken to the Accumulated Other Comprehensive Income.

Commitments and Contingencies

Liabilities for loss contingencies, arising from claims, assessments, litigation, fines, and penalties and other sources are recorded when it is probable that a liability has been incurred and the amount of the assessment can be reasonably estimated. These were nil as at December 31, 2011 (2010: nil).

 

F-23


Universal Biosensors, Inc.

Notes to Consolidated Financial Statements

(for the years ended December 31, 2009, 2010 and 2011)

 

Patent and License Costs

Legal fees incurred for patent application costs have been charged to expense and reported in research and development expense. Legal fees incurred for patents relating to commercialized products are capitalized and amortized over the life of the patents.

Clinical Trial Expenses

Clinical trial costs are a component of research and development expenses. These expenses include fees paid to participating hospitals and other service providers, which conduct certain testing activities on behalf of the Company. Depending on the timing of payments to the service providers and the level of service provided, the Company records prepaid or accrued expenses relating to these costs.

These prepaid or accrued expenses are based on estimates of the work performed under service agreements.

Leased Assets

All of the Company’s leases for the years ended December 31, 2011, 2010 and 2009 are considered operating leases. The costs of operating leases are charged to the statement of operations on a straight-line basis over the lease term.

Stock-based Compensation

We measure stock-based compensation at grant date, based on the estimated fair value of the award, and recognize the cost as an expense on a straight-line basis over the vesting period of the award. We estimate the fair value of stock options using the Trinomial Lattice model. We also grant our employees Restricted Stock Units (“RSUs”) and Zero Priced Employee Options (“ZEPOs”). RSUs are stock awards granted to employees that entitle the holder to shares of common stock as the award vests. ZEPOs are stock options granted to employees that entitle the holder to shares of common stock as the award vests. The value of RSUs and ZEPOs are determined and fixed on the grant date based on the Company’s stock price. See note 5 for further details.

We record deferred tax assets for awards that will result in deductions on our income tax returns, based on the amount of compensation cost recognized and our statutory tax rate in the jurisdiction in which we will receive a deduction. Differences between the deferred tax assets recognized for financial reporting purposes and the actual tax deduction reported in our income tax return are recorded in expense or in capital in excess of par value if the tax deduction exceeds the deferred tax assets or to the extent that previously recognized credits to paid-in-capital are still available if the tax deduction is less than the deferred tax asset.

Employee Benefit Costs

The Company contributes to standard defined contribution superannuation funds on behalf of all employees at nine percent of each such employee’s salary. Superannuation is a compulsory savings program whereby employers are required to pay a portion of an employee’s remuneration to an approved superannuation fund that the employee is typically not able to access until they are retired. The Company permits employees to choose an approved and registered superannuation fund into which the contributions are paid. Contributions are charged to the statement of operations as they become payable.

Net Profit/(Loss) per Share and Anti-dilutive Securities

Basic and diluted net profit/(loss) per share is presented in conformity with ASC 260 – Earnings per Share. Basic and diluted net profit/(loss) per share has been computed using the weighted-average number of common shares outstanding during the period. Other than in a profit making year, the potentially dilutive options issued under the Universal Biosensors Employee Option Plan were not considered in the computation of diluted net profit/(loss) per share because they would be anti-dilutive given the Company’s loss making position.

 

F-24


Universal Biosensors, Inc.

Notes to Consolidated Financial Statements

(for the years ended December 31, 2009, 2010 and 2011)

 

Total Comprehensive Income

The Company follows ASC 220 – Comprehensive Income. Comprehensive income is defined as the total change in shareholders’ equity during the period other than from transactions with shareholders, and for the Company, includes net income and cumulative translation adjustments.

Recent Accounting Pronouncements

In December 2011, the FASB issued ASU 2011-11 which amended the disclosure requirements regarding offsetting assets and liabilities of derivatives, sale and repurchase agreements, reverse sale and repurchase agreements, and securities borrowing and securities lending arrangements. The enhanced disclosures will require entities to provide both net and gross information for these assets and liabilities. The amendment is effective for fiscal years beginning on or after January 1, 2013. The Company does not anticipate that this amendment will have a material impact on its financial statements.

In June 2011, the FASB issued ASU No. 2011-05, Comprehensive Income (Topic 220): Presentation of Comprehensive Income. The new guidance allows an entity to present components of net income and other comprehensive income in one continuous statement, referred to as the statement of comprehensive income, or in two separate, but consecutive statements. The guidance eliminates the current option to report other comprehensive income and its components in the statement of changes in equity. While the new guidance changes the presentation of comprehensive income, there are no changes to the components that are recognized in net income or other comprehensive income under current accounting guidance. This new guidance is effective for fiscal years and interim periods beginning after December 15, 2011. This guidance will result in a change in the way we present Other Comprehensive Income and its components, but will not have an impact on our financial position, results of operations or cash flows.

In May 2011, the FASB issued ASU No. 2011-04, Fair Value Measurement (Topic 820): Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. generally accepted accounting principles (GAAP) and International Financial Reporting Standards (IFRS). This ASU is intended to result in convergence between U.S. GAAP and IFRS requirements for measurement of and disclosures about fair value. The guidance amends current fair value measurement and disclosure guidance to include increased transparency around valuation inputs and investment categorization. This new guidance is effective for fiscal years and interim periods beginning after December 15, 2011. We do not believe the adoption of the new guidance will have a significant impact on the company’s consolidated financial statements.

 

(3)  Commitments and Contingent Liabilities

Operating Leases

UBS entered into a lease with respect to premises at 1 Corporate Avenue, Rowville Victoria which commenced on November 1, 2006 for an initial period of seven years and five months, with two options to renew the lease for successive five-year periods. The Company’s primary bank has issued a bank guarantee of A$250,000 in relation to a rental bond to secure the payments under the lease. This bank guarantee is secured by a security deposit held at the bank and has been recorded as “Other Assets” in Consolidated Balance Sheets.

In accordance with the terms of the lease, the lessee has to restore part of the building upon vacating the premises.

The Company has also entered into a lease with respect to certain office equipment. The lease is for a period of 60 months which commenced in December 2007.

 

 

F-25


Universal Biosensors, Inc.

Notes to Consolidated Financial Statements

(for the years ended December 31, 2009, 2010 and 2011)

 

Future minimum lease payments under non-cancelable operating leases (with initial or remaining lease terms in excess of one year) as of December 31, 2011 are:

 

     A$  

2012

     556,082   

2013

     567,932   

2014

     146,312   

2015 and thereafter

       
  

 

 

 

Total minimum lease payments

     1,270,326   
  

 

 

 

Rent expense was A$576,301, A$556,584 and A$533,749 for the fiscal years ended December 31, 2011, 2010 and 2009, respectively.

Government research grants

On October 28, 2006, Universal Biosensors Pty Ltd was awarded a grant by the State of Victoria to support the establishment of a medical diagnostic manufacturing facility in Victoria, Australia for the manufacture of new technologies for disease monitoring and to increase support of local and export markets. These payments are subject to the achievement of milestones which include capital expenditure by Universal Biosensors Pty Ltd of predetermined minimum amounts. The State of Victoria may require Universal Biosensors Pty Ltd to refund any amounts paid under the grant together with interest should Universal Biosensors Pty Ltd commit a breach of its obligations under the grant agreement. The State of Victoria may also withhold, suspend, cancel or terminate any payment or payments upon a failure to comply with obligations or if Universal Biosensors Pty Ltd chooses not to proceed with these initiatives or it becomes insolvent. The total amount received under the Victorian State Government Grant during 2011 was A$55,346 (2010: A$39,875, 2009: A$130,000). This grant has been recognized against the acquisition cost of the related plant and equipment.

On October 1, 2010, Universal Biosensors Pty Ltd was awarded a grant of A$250,000 by the State of Victoria to assist in the upgrade of the current manufacturing facility to ultimately support the production of strips for a new point of care test. These payments are subject to the achievement of milestones which include capital expenditure by Universal Biosensors Pty Ltd of predetermined minimum amounts. The State of Victoria may require Universal Biosensors Pty Ltd to refund any amounts paid under the grant together with interest should Universal Biosensors Pty Ltd fail to complete the upgrade within a stipulated timeframe or fails to fulfill its commitments towards the upgrade. The State of Victoria may also withhold, suspend, cancel or terminate any payment or payments upon a failure to comply with obligations or if Universal Biosensors Pty Ltd chooses not to proceed with these initiatives or it becomes insolvent. The total amount received under the Victorian State Government Grant during 2011 was A$175,000 (2010: Nil). This grant has been recognized against the acquisition cost of the related plant and equipment.

Guarantees

There are cross guarantees given by Universal Biosensors, Inc. and Universal Biosensors Pty Ltd as described in note 15. No deficiencies of assets exist in any of these companies. No liability was recognized by the parent entity or the consolidated entity in relation to this guarantee, as the fair value of the guarantees is immaterial.

 

(4)  Income Taxes

The Company is subject to income tax in Australia and is required to pay taxes on its Australian profits. As provided under the Australian income tax laws, the Company and its wholly owned resident subsidiary have formed a tax-consolidated group. Universal Biosensors, Inc. is required to lodge U.S. federal income tax returns. It currently is in a tax loss situation.

 

F-26


Universal Biosensors, Inc.

Notes to Consolidated Financial Statements

(for the years ended December 31, 2009, 2010 and 2011)

 

A reconciliation of the (benefit)/provision for income taxes with the amount computed by applying the Australian statutory company tax rate of 30% to the profit/(loss) before income taxes is as follows:

 

     Years ended December 31,  
     2011     2010     2009  
     A$     %     A$     %     A$     %  

Profit/(loss) before income taxes

     (14,692,117       (6,610,525       1,430,463     

Computed by applying income tax rate of home jurisdiction

     (4,407,635     30        (1,983,157     30        429,139        30   

Research & development incentive

     (635,470     4        (421,341     6        (3,524,333     (246

Disallowed expenses/(income):

            

Share based payment

     676,753        (4     503,100        (7     323,631        22   

Other

     8,849               4,730               (226,924     (16

Change in valuation allowance

     4,357,503        (30     1,896,668        (29     2,998,487        210   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Income tax expense/(benefit)

                                          
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Significant components of the Company’s deferred tax assets are shown below:

 

     As of December 31,  
     2011 A$     2010 A$  

Deferred tax assets:

    

Operating loss carry forwards

     16,794,322        12,923,654   

Unamortized capital raising cost

     1,000        104,850   

Depreciation and amortization

     (378,385     (663,990

Asset retirement obligations

     650,007        599,418   

Employee entitlements

     301,860        227,090   

Other

     987,644        807,923   
  

 

 

   

 

 

 

Total deferred tax assets

     18,356,448        13,998,945   

Valuation allowance for deferred tax assets

     (18,356,448     (13,998,945
  

 

 

   

 

 

 

Net deferred tax asset

              
  

 

 

   

 

 

 

Significant components of deferred income taxes reflect the net tax effect of temporary differences between the carrying amounts of assets and liabilities for financial reporting and tax purposes. A valuation allowance has been established, as realization of such assets is not more likely than not.

At December 31, 2011 the Company has A$55,981,074 (A$43,078,848 at December 31, 2010) of accumulated tax losses available for carry forward against future earnings, which under Australian tax laws do not expire but may not be available under certain circumstances.

 

(5)  Employee Incentive Schemes

(a)  Stock Option Plan

In 2004, the Company adopted an employee option plan (“Plan”). Options may be granted pursuant to the Plan to any person considered by the board to be employed by the Group on a permanent basis (whether full time, part time or on a long term casual basis). Each option gives the holder the right to subscribe for one share of common stock. The total number of options that may be issued under the Plan is such maximum amount permitted by law and the Listing Rules of the Australian Securities Exchange (“ASX”). The exercise price and

 

F-27


Universal Biosensors, Inc.

Notes to Consolidated Financial Statements

(for the years ended December 31, 2009, 2010 and 2011)

 

any exercise conditions are determined by the board at the time of grant of the options. Any exercise conditions must be satisfied before the options vest and become capable of exercise. The options lapse on such date determined by the board at the time of grant or earlier in accordance with the Plan. Options granted to date have had a term up to 10 years and generally vest in equal tranches over three years.

An option holder is not permitted to participate in a bonus issue or new issue of securities in respect of an option held prior to the issue of shares to the option holder pursuant to the exercise of an option. If Universal Biosensors changes the number of issued shares through or as a result of any consolidation, subdivision, or similar reconstruction of the issued capital of the Company, the total number of options and the exercise price of the options (as applicable) will likewise be adjusted. Options granted in 2009, 2010 and 2011 were 4,164,200, 914,500 and 3,555,500 respectively.

In accordance with ASC 718, the fair value of the option grants was estimated on the date of each grant using the Trinomial Lattice model. The assumptions for these grants were:

 

    Grant Date  
    Nov-11     Nov-11     Sep-11     Mar-11     Feb-11     Nov-10     Nov-10     Feb-10     Nov-09     Jun-09     Jun-09     May-09     Feb-09  

Exercise Price (A$)

    Nil        0.89        1.00        1.37        1.38        Nil        1.58        1.6        1.72        Nil        0.94        Nil        0.5   

Share Price at Grant Date (A$)

    0.89        0.89        1.00        1.37        1.38        1.58        1.58        1.6        1.73        0.95        0.95        1.18        0.43   

Volatility

    68     68     69     70     71     72     72     77     78     80     80     81     77

Expected Life (years)

    7        7        7        7        7        7        7        7        10        10        10        10        10   

Risk Free Interest Rate

    3.72     3.72     3.89     5.36     5.45     5.27     5.27     5.34     5.63     5.49     5.49     4.87     4.26

Fair Value of Option (A$)

    0.89        0.52        0.59        0.83        0.83        1.58        0.96        0.99        1.13        0.95        0.62        1.04        0.28   

Each of the inputs to the Trinomial Lattice model is discussed below.

Share price at valuation date

The value of the options granted in 2010 and 2011 has been determined using the closing price of our common stock trading in the form of CDIs on ASX at the time of grant of the options. The value of the options granted in 2009 have been determined using the average closing price of the Company’s common stock on the ASX on the five days on which the Company’s common stock has traded prior to the approval of grant. The ASX is the only exchange upon which our securities are quoted.

Volatility

We applied volatility having regard to the historical price change of our shares in the form of CDIs available from the ASX.

Time to Expiry

All options granted under our share option plan have a maximum 10 year term and are non-transferable.

Risk free rate

The risk free rate which we applied is equivalent to the yield on an Australian government bond with a time to expiry approximately equal to the expected time to expiry on the options being valued.

 

F-28


Universal Biosensors, Inc.

Notes to Consolidated Financial Statements

(for the years ended December 31, 2009, 2010 and 2011)

 

Stock option activity during the current period is as follows:

 

     Number of
shares
    Weighted
average
exercise price
 
           A$  

Balance at December 31, 2010

     8,539,704        0.93   
  

 

 

   

 

 

 

Granted

     3,355,500        1.25   

Exercised

     (181,999     0.46   

Lapsed

     (295,669     1.33   
  

 

 

   

 

 

 

Balance at December 31, 2011

     11,417,536        1.02   
  

 

 

   

 

 

 

At December 31, 2011, the number of options exercisable was 8,011,691 (2010: 5,908,214 and 2009: 5,808,324). At December 31, 2011, total stock compensation expense recognized in income statement was A$2,255,842 (2010: A$1,677,003 and 2009: A$1,078,771).

The following table represents information relating to stock options outstanding under the plans as of December 31, 2011:

 

     Options Outstanding         

Exercise Price

   Shares      Weighted
average
remaining
life in years
     Options
Exercisable
Shares
 
        A$                     

$0.30

     1,516,770         2.00         1,516,770   

$0.35

     443,099         4.00         443,099   

$1.18

     623,000         5.20         623,000   

$1.20

     590,000         5.70         590,000   

$1.13

                       

$0.89

     824,000         6.20         824,000   

$0.70

     224,667         6.60         224,667   

$0.50

     81,333         7.10         81,333   

Nil

     58,334         7.40         58,334   

$0.94

     1,201,000         7.50         1,201,000   

Nil

     410,000         7.50         116,663   

$1.72

     1,568,333         7.90         1,053,345   

$1.60

     50,000         5.10         33,332   

$1.58

     383,500         5.90         127,819   

Nil

     100,000         5.90         33,333   

$1.37

     355,000         6.20         118,330   

$1.38

     2,300,000         6.10         966,666   

$1.00

     86,000         6.70           

$0.89

     502,500         6.90           

Nil

     100,000         6.90           
  

 

 

       

 

 

 
     11,417,536            8,011,691   
  

 

 

       

 

 

 

 

F-29


Universal Biosensors, Inc.

Notes to Consolidated Financial Statements

(for the years ended December 31, 2009, 2010 and 2011)

 

The table below sets forth the number of employee stock options exercised and the number of shares issued in the period from December 31, 2009. We issued these shares in reliance upon exemptions from registration under Regulation S under the Securities Act of 1933, as amended.

 

Period Ending

   Number of  Options
Exercised  and
Corresponding
Number of  Shares
Issued
     Weighted Average
Exercise Price
     Proceeds
Received
 
            A$      A$  

2009

     138,327         0.60         78,998   

2010

     1,667,581         0.49         715,296   

2011

     181,999         0.46         79,504   
  

 

 

       

 

 

 

Total

     1,987,907            873,798   
  

 

 

       

 

 

 

As of December 31, 2011, there was A$1,673,079 of unrecognized compensation expense related to unvested share-based compensation arrangements under the Employee Option Plan. This expense is expected to be recognized as follows:

 

Fiscal Year

   A$  

2012

     1,208,797   

2013

     412,575   

2014

     51,707   
  

 

 

 
     1,673,079   
  

 

 

 

The aggregate intrinsic value for all options outstanding as at December 31, 2011 was zero.

(b)  Restricted Share Plan

Our Employee Share Plan was adopted by the Board of Directors in 2009. The Employee Share Plan permits our Board to grant shares of our common stock to our employees and directors. The number of shares able to be granted is limited to the amount permitted to be granted at law, the ASX Listing Rules and by the limits on our authorized share capital in our certificate of incorporation. All our employees are eligible for shares under the Employee Plan. The Company currently proposes to continue to issue A$1,000 worth of restricted shares of common stock to employees of the Company on a recurring basis, but no more frequently than annually. The restricted shares have the same terms of issue as our existing shares of common stock but are not able to be traded until the earlier of three years from the date on which the shares are issued or the date the relevant employee ceases to be an employee of the Company or any of its associated group of companies.

The table below sets forth the restricted shares issued by the Company:

 

     Number of
Restricted
Shares Issued
     Market
Value of
Restricted
Shares Issued
 

November, 2009

     40,670       A$ 69,952   

May, 2010

     581       A$ 999   

November, 2010

     47,400       A$ 74,892   

November, 2011

     86,471       A$ 76,959   

 

F-30


Universal Biosensors, Inc.

Notes to Consolidated Financial Statements

(for the years ended December 31, 2009, 2010 and 2011)

 

Restricted stock awards activity during the current period is as follows:

 

     Number of
shares
    Weighted
average
issue price
 
           A$  

Balance at December 31, 2010

     82,841        1.64   
  

 

 

   

 

 

 

Granted

     86,471        0.89   

Release of restricted shares

     (11,549     1.64   
  

 

 

   

 

 

 

Balance at December 31, 2011

     157,763        1.23   
  

 

 

   

 

 

 

 

(6)  Related Party Transactions

Details of related party transactions material to the operations of the Group other than compensation arrangements, expense allowances, and other similar items in the ordinary course of business, are set out below:

In September 2011, we entered into a license agreement with SpeeDx Pty Ltd (“SpeeDx”) pursuant to which SpeeDx granted us a license in the field of molecular diagnostics. Under the agreement we make milestone payments totaling A$500,000 if certain specified targets are achieved and payments ranging from 5% to 15% of our sales and licensing revenues to SpeeDx. Messrs Denver and Jane are directors of the Company and SpeeDx Pty Ltd. Certain of our substantial shareholders also hold substantial shareholdings in SpeeDx. CM Capital Pty Ltd, which holds approximately 11% of our shares and of which Mr Jane is a director, holds approximately 34% of the issued shares in SpeeDx. PFM Cornerstone Limited, which holds approximately 8% of our shares and of which Messrs Denver and Hanley and Dr Adam are directors, holds approximately 34% of the issued shares in SpeeDx. Johnson & Johnson Development Corporation has a beneficial interest in approximately 9% of our shares. An affiliate of Johnson & Johnson, Johnson and Johnson Research Pty Ltd owns approximately 13% of issued shares in SpeeDx.

Based on the latest Amendment to Schedule 13G filed on January 25, 2012, Johnson and Johnson Development Corporation (a venture capital wholly owned subsidiary of Johnson & Johnson) beneficially held 14,915,400 shares in the Company as at December 31, 2011 which represents approximately 9.4% of the Company’s shares.

The following transactions occurred with LifeScan:

 

     As of December, 31  
     2011      2010      2009  
     A$      A$      A$  

Current Receivables — Owing by LifeScan

        

Sale of goods

     1,999,764         3,588,798      

Sale of services

     2,890,019              
  

 

 

    

 

 

    
     4,889,783         3,588,798      
  

 

 

    

 

 

    

Current Liabilities — Owing to LifeScan

        

Purchase of goods

     786,708              
  

 

 

    

 

 

    

Revenue from LifeScan

        

Revenue from products

     12,063,582         11,760,009         132,733   

Revenue from services

     2,632,870         6,420,027         2,850,071   

Research and develoment income

                     1,337,125   

Milestone payment

                     17,722,641   
  

 

 

    

 

 

    

 

 

 
     14,696,452         18,180,036         22,042,570   
  

 

 

    

 

 

    

 

 

 

 

F-31


Universal Biosensors, Inc.

Notes to Consolidated Financial Statements

(for the years ended December 31, 2009, 2010 and 2011)

 

(7)  Financial Instruments

Financial Assets

 

     Years Ended December 31,  
     2011      2010      2009  
     A$      A$      A$  

Financial assets:

        

Cash and cash equivalents

     15,089,209         23,271,766         31,291,011   

Accounts receivables

     4,889,783         3,588,798         415,397   

Financial instruments

     83,339                   
  

 

 

    

 

 

    

 

 

 

Total financial assets

     20,062,331         26,860,564         31,706,408   
  

 

 

    

 

 

    

 

 

 

Debt:

        

Short and long term debt/borrowings

                       

Financial instruments

                     47,412   
  

 

 

    

 

 

    

 

 

 

Total debt

                     47,412   
  

 

 

    

 

 

    

 

 

 

Net financial assets

     20,062,331         26,860,564         31,658,996   
  

 

 

    

 

 

    

 

 

 

The carrying value of the cash and cash equivalents and the accounts receivables approximates fair value because of their short-term nature.

We regularly review all our financial assets for impairment. There were no impairments recognized in 2011, 2010 and 2009.

Derivative Instruments and Hedging Activities

In determining fair value, we utilize valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible as well as consider our own and counterparty credit risk. At December 31, 2011 and 2010 we did not have any assets or liabilities that utilize Level 3 inputs. The valuation of our foreign exchange derivatives are based on the market approach using observable market inputs, such as forward rates and incorporate non-performance risk (the credit standing of the counterparty when the derivative is in a net asset position, and the credit standing of the Company when the derivative is in a net liability position). Our derivative assets are categorized as Level 2.

At December 31, 2011 (2010: nil) we had outstanding contracts with a notional amount of US$4.0 million. The fair value of these contracts at December 31, 2011 (2010: nil) was an asset of A$83,339 recorded as ‘Financial Instruments’ in consolidated balance sheet. As of December 31, 2011, substantially all of the derivative gain recognized in accumulated other comprehensive income (AOCI) will be recognized in earnings within the next 12 months. No amount of ineffectiveness was recorded in earnings for these designated cash flow hedges for the year ended December 31, 2011 (2010: nil). For further details, see Notes to Consolidated Financial Statements — Note 2. Summary of Significant Accounting Policies.

 

F-32


Universal Biosensors, Inc.

Notes to Consolidated Financial Statements

(for the years ended December 31, 2009, 2010 and 2011)

 

(8)  Property, Plant and Equipment

 

     As of December, 31  
     2011     2010  
     A$     A$  

Plant and equipment

     18,893,890        15,110,554   

Leasehold improvements

     8,722,639        8,810,036   

Capital work in process

     5,534,498        8,792,690   
  

 

 

   

 

 

 
     33,151,027        32,713,280   

Accumulated depreciation

     (12,855,847     (9,586,365
  

 

 

   

 

 

 

Property, plant & equipment, net

     20,295,180        23,126,915   
  

 

 

   

 

 

 

Capital work in process relates to assets under construction and comprises primarily of specialized manufacturing equipment. Legal right to the assets under construction rests with the Company. The amounts capitalized for capital work in process represents the percentage of expenditure that has been completed, and once the assets are placed into service the Company begins depreciating the respective assets. The accumulated amortisation of capitalised leasehold improvements for the fiscal years ended December 31, 2011, 2010 and 2009 was A$5,376,432, A$4,090,724 and A$2,770,434, respectively.

The Company receives Victorian government grants under certain research agreements to purchase plant and equipment. Plant and equipment is presented net of the government grant of A$680,221 for the year ended December 31, 2011 (2010: A$449,875). The grants are recognized against the acquisition costs of the related plant and equipment as and when the related assets are purchased. Grants received in advance of the relevant expenditure are treated as deferred income and included in Current Liabilities on the balance sheet as the Company does not control the monies until the relevant expenditure has been incurred. Grants due to the Company under research agreements are recorded as Currents Assets on the consolidated balance sheets.

Depreciation expense was A$3,298,541, A$2,990,858 and A$2,851,285 for the fiscal years ended December 31, 2011, 2010 and 2009, respectively.

 

(9)  Accrued Expenses

Accrued expenses consist of the following:

 

     As of December, 31  
     2011      2010  
     A$      A$  

Legal, tax and accounting fees

     511,121         591,184   

Salary and related costs

     706,053         587,695   

Research and development materials

     35,050         120,000   

Production materials

     786,708         657,142   

Other

     22,596         143,456   
  

 

 

    

 

 

 
     2,061,528         2,099,477   
  

 

 

    

 

 

 

 

(10)  Stockholders’ Equity — Common Stock

Holders of common stock are generally entitled to one vote per share held on all matters submitted to a vote of the holders of common stock. At any meeting of the shareholders, the presence, in person or by proxy, of the

 

F-33


Universal Biosensors, Inc.

Notes to Consolidated Financial Statements

(for the years ended December 31, 2009, 2010 and 2011)

 

majority of the outstanding stock entitled to vote shall constitute a quorum. Except where a greater percentage is required by the Company’s Amended and Restated Certificate of Incorporation or By-laws, the affirmative vote of the holders of a majority of the shares of common stock then represented at the meeting and entitled to vote at the meeting shall be sufficient to pass a resolution. Holders of common stock are not entitled to cumulative voting rights with respect to the election of directors, and the common stock does not have pre-emptive rights.

Trading in our shares of common stock on ASX is undertaken using CHESS Depositary Interests (“CDIs”). Each CDI represents beneficial ownership in one underlying share. Legal title to the shares underlying CDIs is held by CHESS Depositary Nominees Pty Ltd (“CDN”), a wholly owned subsidiary of ASX.

Holders of CDIs have the same economic benefits of holding the shares, such as dividends (if any), bonus issues or rights issues as though they were holders of the legal title. Holders of CDIs are not permitted to vote but are entitled to direct CDN how to vote. Subject to Delaware General Corporation Law, dividends may be declared by the Board and holders of common stock may be entitled to participate in such dividends from time to time.

 

(11)  Retirement Benefits

Universal Biosensors Pty Ltd contributes to standard defined contributions superannuation funds on behalf of all employees at an amount up to nine per cent of employee salary. The Company permits employees to choose the superannuation fund into which the contributions are paid, provided the fund is appropriately registered.

Universal Biosensors Pty Ltd contributed A$806,158, A$714,123 and A$698,919 for the fiscal years ended December 31, 2011, 2010 and 2009, respectively.

 

(12)  Net Profit/(Loss) per Share

Basic net profit/(loss) per ordinary share was computed by dividing the net profit/(loss) applicable to common stock by the weighted-average number of common stock outstanding during the period. Options granted to employees under the Universal Biosensors Employee Option Plan are considered to be potential ordinary shares for the purpose of calculating diluted net profit/(loss) per share. However, all these were not included in the calculation of diluted net profit/(loss) per share in the year when the Group made a net loss as the effect of including them is anti-dilutive.

 

     Years Ended December 31,  
     2011      2010      2009  

Weighted average shares used as denominator in calculating:

        

Basic net profit/(loss) per share

     159,017,777         157,584,044         157,013,578   
  

 

 

    

 

 

    

 

 

 

Diluted net profit/(loss) per share

     159,017,777         157,584,044         161,354,802   
  

 

 

    

 

 

    

 

 

 

 

(13) Guarantees and Indemnifications

The certificate of incorporation and amended and restated by-laws of the Company provide that the Company will indemnify officers and directors and former officers and directors in certain circumstances, including for expenses, judgments, fines and settlement amounts incurred by them in connection with their services as an officer or director of the Company or its subsidiaries, provided that such person acted in good faith and in a manner such person reasonably believed to be in the best interests of the Company.

 

F-34


Universal Biosensors, Inc.

Notes to Consolidated Financial Statements

(for the years ended December 31, 2009, 2010 and 2011)

 

In addition to the indemnities provided in the certificate of incorporation and amended and restated by-laws, the Company has entered into indemnification agreements with certain of its officers and each of its directors. Subject to the relevant limitations imposed by applicable law, the indemnification agreements, among other things:

 

  Ÿ  

indemnify the relevant officers and directors for certain expenses, judgments, fines and settlement amounts incurred by them in connection with their services as an officer or director of the Company or its subsidiaries; and

 

  Ÿ  

require the Company to make a good faith determination whether or not it is practicable to maintain liability insurance for officers and directors or to ensure the Company’s performance of its indemnification obligations under the agreements.

The Company maintains directors’ and officers’ liability insurance providing for the indemnification of our directors and certain of our officers against certain liabilities incurred as a director or officer, including costs and expenses associated in defending legal proceedings. In accordance with the terms of the insurance policy and commercial practice, the amount of the premium is not disclosed.

No liability has arisen under these indemnities as at December 31, 2011.

 

(14)  Segments

The Company operates in one segment. The principal activities of the Company are research and development, commercial manufacture of approved medical or testing devices and the provision of services including contract research work.

The Company operates predominantly in one geographical area, being Australia.

 

(15)  Deed of Cross Guarantee

Universal Biosensors, Inc. and its wholly owned subsidiary, Universal Biosensors Pty Ltd, are parties to a deed of cross guarantee under which each company guarantees the debts of the other. By entering into the deed, the wholly-owned entity has been relieved from the requirements to prepare a financial report and directors’ report under Class Order 98/1418 (as amended) issued by the Australian Securities and Investments Commission.

The above companies represent a “Closed Group” for the purposes of the Class Order, and as there are no other parties to the Deed of Cross Guarantee that are controlled by Universal Biosensors, Inc., they also represent the “Extended Closed Group”.

The consolidated financial statements presented within this report comprise that of Universal Biosensors, Inc. and its wholly owned subsidiary, Universal Biosensors Pty Ltd. These two entities also represent the “Closed Group” and the “Extended Closed Group”.

 

F-35


Schedule Valuation and Qualifying Accounts

Universal Biosensors, Inc.

Schedule ii — Valuation and Qualifying Accounts

(for the years ended December 31, 2009, 2010 and 2011)

 

          Additions              
    Balance at
Beginning  of
Period
    Charged to
Costs  and
Expenses
    Charged to
Other
Accounts
    Deductions     Balance at
end of  Period
 
    A$     A$     A$     A$     A$  

Year ended December 31, 2009

         

Deferred income tax valuation allowance

    10,601,120        2,998,487               (1,899,796     11,699,811   

Year ended December 31, 2010

         

Deferred income tax valuation allowance

    11,699,811        1,896,668        372,305               13,968,784   

Year ended December 31, 2011

         

Deferred income tax valuation allowance

    13,968,784        4,357,503        30,161               18,356,448   

 

F-36

EX-31.1 4 d266783dex311.htm CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER PURSUANT TO SECTION 302 Certification of Principal Executive Officer pursuant to Section 302

Exhibit 31.1

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO

SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Paul Wright, certify that:

 

1. I have reviewed this report on Form 10-K of Universal Biosensors, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

  b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

  c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

  d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

  b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: March 13, 2012

 

/s/ Paul Wright
Paul Wright
Principal Executive Officer
Universal Biosensors, Inc.
EX-31.2 5 d266783dex312.htm CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER PURSUANT TO SECTION 302 Certification of Principal Financial Officer pursuant to Section 302

Exhibit 31.2

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO

SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Salesh Balak, certify that:

 

1. I have reviewed this report on Form 10-K of Universal Biosensors, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

  b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

  c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

  d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

  b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: March 13, 2012

 

/s/ Salesh Balak
Salesh Balak
Principal Financial Officer
Universal Biosensors, Inc.
EX-32.0 6 d266783dex320.htm CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER AND PRINCIPAL FINANCIAL OFFICER Certification of Principal Executive Officer and Principal Financial Officer

Exhibit 32.0

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 *

In connection with the annual report of Universal Biosensors, Inc. (the “Company”) on Form 10-K for the period ended December 31, 2011, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), each of the undersigned officers of the Company does hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to the best of such officer’s knowledge:

 

  (1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

  (2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. The undersigned have executed this Certificate as of the 13th day of March 2012.

 

/s/ Paul Wright
Paul Wright
Principal Executive Officer

 

/s/ Salesh Balak
Salesh Balak
Principal Financial Officer

 

* This certification is being furnished as required by Rule 13a-14(b) under the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), and Section 1350 of Chapter 63 of Title 18 of the United States Code, and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that section. This certification shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except to the extent such certification is explicitly incorporated by reference in such filing.
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Commitments and Contingent Liabilities
12 Months Ended
Dec. 31, 2011
Commitments and Contingent Liabilities [Abstract]  
Commitments and Contingent Liabilities
(3)  Commitments and Contingent Liabilities

Operating Leases

UBS entered into a lease with respect to premises at 1 Corporate Avenue, Rowville Victoria which commenced on November 1, 2006 for an initial period of seven years and five months, with two options to renew the lease for successive five-year periods. The Company’s primary bank has issued a bank guarantee of A$250,000 in relation to a rental bond to secure the payments under the lease. This bank guarantee is secured by a security deposit held at the bank and has been recorded as “Other Assets” in Consolidated Balance Sheets.

In accordance with the terms of the lease, the lessee has to restore part of the building upon vacating the premises.

The Company has also entered into a lease with respect to certain office equipment. The lease is for a period of 60 months which commenced in December 2007.

 

Future minimum lease payments under non-cancelable operating leases (with initial or remaining lease terms in excess of one year) as of December 31, 2011 are:

 

         
    A$  

2012

    556,082  

2013

    567,932  

2014

    146,312  

2015 and thereafter

     
   

 

 

 

Total minimum lease payments

    1,270,326  
   

 

 

 

Rent expense was A$576,301, A$556,584 and A$533,749 for the fiscal years ended December 31, 2011, 2010 and 2009, respectively.

Government research grants

On October 28, 2006, Universal Biosensors Pty Ltd was awarded a grant by the State of Victoria to support the establishment of a medical diagnostic manufacturing facility in Victoria, Australia for the manufacture of new technologies for disease monitoring and to increase support of local and export markets. These payments are subject to the achievement of milestones which include capital expenditure by Universal Biosensors Pty Ltd of predetermined minimum amounts. The State of Victoria may require Universal Biosensors Pty Ltd to refund any amounts paid under the grant together with interest should Universal Biosensors Pty Ltd commit a breach of its obligations under the grant agreement. The State of Victoria may also withhold, suspend, cancel or terminate any payment or payments upon a failure to comply with obligations or if Universal Biosensors Pty Ltd chooses not to proceed with these initiatives or it becomes insolvent. The total amount received under the Victorian State Government Grant during 2011 was A$55,346 (2010: A$39,875, 2009: A$130,000). This grant has been recognized against the acquisition cost of the related plant and equipment.

On October 1, 2010, Universal Biosensors Pty Ltd was awarded a grant of A$250,000 by the State of Victoria to assist in the upgrade of the current manufacturing facility to ultimately support the production of strips for a new point of care test. These payments are subject to the achievement of milestones which include capital expenditure by Universal Biosensors Pty Ltd of predetermined minimum amounts. The State of Victoria may require Universal Biosensors Pty Ltd to refund any amounts paid under the grant together with interest should Universal Biosensors Pty Ltd fail to complete the upgrade within a stipulated timeframe or fails to fulfill its commitments towards the upgrade. The State of Victoria may also withhold, suspend, cancel or terminate any payment or payments upon a failure to comply with obligations or if Universal Biosensors Pty Ltd chooses not to proceed with these initiatives or it becomes insolvent. The total amount received under the Victorian State Government Grant during 2011 was A$175,000 (2010: Nil). This grant has been recognized against the acquisition cost of the related plant and equipment.

Guarantees

There are cross guarantees given by Universal Biosensors, Inc. and Universal Biosensors Pty Ltd as described in note 15. No deficiencies of assets exist in any of these companies. No liability was recognized by the parent entity or the consolidated entity in relation to this guarantee, as the fair value of the guarantees is immaterial.

 

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Summary of Significant Accounting Policies
12 Months Ended
Dec. 31, 2011
Summary of Significant Accounting Policies [Abstract]  
Summary of Significant Accounting Policies
(2)  Summary of Significant Accounting Policies

Principles of Consolidation

The consolidated financial statements include the financial statements of the Company and its wholly owned subsidiary UBS. All intercompany balances and transactions have been eliminated on consolidation.

Use of Estimates

The preparation of the consolidated financial statements requires management of the Company to make a number of estimates and assumptions relating to the reported amount of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the period. Significant items subject to such estimates and assumptions include the carrying amount of property, plant and equipment, deferred income taxes, asset retirement obligations and obligations related to employee benefits. Actual results could differ from those estimates.

Reclassification

Certain prior year amounts have been reclassified to conform to the current year presentation.

Cash & Cash Equivalents

The Company considers all highly liquid investments purchased with an initial maturity of three months or less to be cash equivalents. For cash and cash equivalents, the carrying amount approximates fair value due to the short maturity of those instruments.

Short-Term Investments (Held-to-maturity)

Short-term investments constitute all highly liquid investments with term to maturity from three months to twelve months. The carrying amount of short-term investments is equivalent to its fair value.

Concentration of Credit Risk and Other Risks and Uncertainties

Cash and cash equivalents and accounts receivables consists of financial instruments that potentially subject the Company to concentration of credit risk to the extent of the amount recorded on the balance sheet. The Company’s cash and cash equivalents are invested with two of Australia’s four largest banks. The Company is exposed to credit risk in the event of default by the banks holding the cash or cash equivalents to the extent of the amount recorded on the balance sheets. The Company has not experienced any losses on its deposits of cash and cash equivalents. The Company has not identified any collectability issues with respect to receivables.

Derivative Instruments and Hedging Activities

Derivative financial instruments

The Company uses derivative financial instruments to hedge its exposure to foreign exchange arising from operating, investing and financing activities. The Company does not hold or issue derivative financial instruments for trading purposes. However, derivatives that do not qualify for hedge accounting are accounted for as trading instruments.

Derivative financial instruments are recognized initially at fair value. Subsequent to initial recognition, derivative financial instruments are stated at fair value. The gain or loss on remeasurement to fair value is recognized immediately in the income statement. However, where derivatives qualify for hedge accounting, recognition of any resultant gain or loss depends on the nature of the item being hedged.

Cash flow hedges

Exposure to foreign exchange risks arises in the normal course of the Company’s business and it is the Company’s policy to use forward exchange contracts to hedge anticipated sales and purchases in foreign currencies. The amount of forward cover taken is in accordance with approved policy and internal forecasts.

Where a derivative financial instrument is designated as a hedge of the variability in cash flows of a recognized asset or liability, or a highly probable forecast transaction, the effective part of any unrealised gain or loss on the derivative financial instrument is recognized directly in equity. When the forecast transaction subsequently results in the recognition of a non-financial asset or non-financial liability, the associated cumulative gain or loss is removed from equity and included in the initial cost or other carrying amount of the non-financial asset or liability.

For cash flow hedges, other than those covered by the preceding statement, the associated cumulative gain or loss is removed from equity and recognized in the consolidated statements of operations in the same period or periods during which the hedged forecast transaction affects the consolidated statements of operations and on the same line item as that hedged forecast transaction. The ineffective part of any gain or loss is recognized immediately in the consolidated statements of operations.

When a hedging instrument expires or is sold, terminated or exercised, or the Company revokes designation of the hedge relationship but the hedged forecast transaction is still probable to occur, the cumulative gain or loss at that point remains in equity and is recognized in accordance with the above policy when the transaction occurs. If the hedged transaction is no longer expected to take place, then the cumulative unrealized gain or loss recognized in equity is recognized immediately in the consolidated statements of operations.

Inventory

Inventories are stated at the lower of cost or net realizable value. Net realizable value is the estimated selling price in the ordinary course of business less the estimated costs of completion and estimated costs necessary to dispose. Inventories are principally determined under the average cost method which approximates cost. Cost comprises direct materials, direct labour and an appropriate portion of variable and fixed overhead expenditure, the latter being allocated on the basis of normal operating capacity. Cost also includes the transfer from equity of any gains/losses on qualifying cash flow hedges relating to purchases of raw material. Costs of purchased inventory are determined after deducting rebates and discounts.

 

                         
    Years Ended December 31,  
    2011     2010     2009  
    A$     A$     A$  

Raw materials

    3,254,675       2,798,045       289,069  

Work in progress

    102,239       188,629       16,055  

Finished goods

    262,486       204,419        
   

 

 

   

 

 

   

 

 

 
      3,619,400       3,191,093       305,124  
   

 

 

   

 

 

   

 

 

 

Receivables

Trade accounts receivable are recorded at the invoiced amount and do not bear interest. The allowance for doubtful accounts is the best estimate of the amount of probable credit losses in the existing accounts receivable. The allowance is determined based on a review of individual accounts for collectibility, generally focusing on those accounts that are past due. The current year expense to adjust the allowance for doubtful accounts, if any, is recorded within general and administrative expenses in the consolidated statements of operations. Account balances are charged against the allowance when it is probable the receivable will not be recovered.

 

                         
    Years Ended December 31,  
    2011     2010     2009  
    A$     A$     A$  

Accounts receivable

    4,889,783       3,588,798       415,397  

Allowance for doubtful debts

                 
   

 

 

   

 

 

   

 

 

 
      4,889,783       3,588,798       415,397  
   

 

 

   

 

 

   

 

 

 

Property, Plant, and Equipment

Property, plant, and equipment are recorded at acquisition cost, less accumulated depreciation.

Depreciation on plant and equipment is calculated using the straight-line method over the estimated useful lives of the assets. The estimated useful life of machinery and equipment is 3 to 10 years. Leasehold improvements are amortized on the straight-line method over the shorter of the remaining lease term or estimated useful life of the asset. Maintenance and repairs are charged to operations as incurred and include normal services and does not include items of a capital nature.

The Company receives Victorian government grant monies under grant agreements to support our development activities, including in connection with the purchase of plant and equipment. Plant and equipment is presented net of the government grant. The grant monies are recognized against the acquisition costs of the related plant and equipment as and when the related assets are purchased.

Research and Development

Research and development expenses consist of costs incurred to further the Group’s research and development activities and include salaries and related employee benefits, costs associated with clinical trial and preclinical development, regulatory activities, research-related overhead expenses, costs associated with the manufacture of clinical trial material, costs associated with developing a commercial manufacturing process, costs for consultants and related contract research, facility costs and depreciation. Research and development costs are expensed as incurred.

 

Research and development expenses for years ended December 31, 2011, 2010 and 2009 are as follows:

 

                         
    Years Ended December 31,  
    2011     2010     2009  
    A$     A$     A$  

Research and development expenses

    9,812,396       6,482,150       14,898,072  
   

 

 

   

 

 

   

 

 

 

Income Taxes

The Company applies ASC 740 — Income Taxes which establishes financial accounting and reporting standards for the effects of income taxes that result from a company’s activities during the current and preceding years. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carry forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.

Where it is more likely than not that some portion or all of the deferred tax assets will not be realized the deferred tax assets are reduced by a valuation allowance. The valuation allowance is sufficient to reduce the deferred tax assets to the amount that is more likely than not to be realized. A reconciliation of the valuation and qualifying accounts is attached as Schedule ii.

We are subject to income taxes in the United States and Australia. U.S. federal income tax returns up to the 2010 financial year have been filed. Internationally, consolidated income tax returns up to the 2010 financial year have been filed.

Asset Retirement Obligations

Asset retirement obligations (“ARO”) are legal obligations associated with the retirement and removal of long-lived assets. ASC 410 – Asset Retirement and Environmental Obligations requires entities to record the fair value of a liability for an asset retirement obligation when it is incurred. When the liability is initially recorded, the Company capitalizes the cost by increasing the carrying amounts of the related property, plant and equipment. Over time, the liability increases for the change in its present value, while the capitalized cost depreciates over the useful life of the asset. The Company derecognizes ARO liabilities when the related obligations are settled.

The ARO is in relation to our premises where in accordance with the terms of the lease, the lessee has to restore part of the building upon vacating the premises.

Our overall ARO changed as follows:

 

                 
    Years Ended December 31,  
    2011     2010  
    A$     A$  

Opening balance at January 1

    1,998,060       1,842,547  

Accretion expense

    168,631       155,513  
   

 

 

   

 

 

 

Ending balance at December 31

    2,166,691       1,998,060  
   

 

 

   

 

 

 

Fair Value of Financial Instruments

The carrying value of all current assets and current liabilities approximates fair value because of their short-term nature. The estimated fair value of all other amounts has been determined, depending on the nature and complexity of the assets or the liability, by using one or all of the following approaches:

 

  Ÿ  

Market approach — based on market prices and other information from market transactions involving identical or comparable assets or liabilities.

 

  Ÿ  

Cost approach — based on the cost to acquire or construct comparable assets less an allowance for functional and/or economic obsolescence.

 

  Ÿ  

Income approach — based on the present value of a future stream of net cash flows

These fair value methodologies depend on the following types of inputs:

 

  Ÿ  

Quoted prices for identical assets or liabilities in active markets (Level 1 inputs)

 

  Ÿ  

Quoted prices for similar assets or liabilities in active markets or quoted prices for identical or similar assets or liabilities in markets that are not active or are directly or indirectly observable (Level 2 inputs)

 

  Ÿ  

Unobservable inputs that reflect estimates and assumptions (Level 3 inputs)

Impairment of Long-Lived Assets

The Company reviews its capital assets, including patents and licenses, for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. In performing the review, the Company estimates undiscounted cash flows from products under development that are covered by these patents and licenses. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of the asset and its eventual disposition is less than the carrying amount of the asset. If the evaluation indicates that the carrying value of an asset is not recoverable from its undiscounted cash flows, an impairment loss is measured by comparing the carrying value of the asset to its fair value, based on discounted cash flows.

Australian Goods and Services Tax (GST)

Revenues, expenses and assets are recognized net of the amount of associated GST, unless the GST incurred is not recoverable from the taxation authority. In this case it is recognized as part of the cost of acquisition of the asset or as part of the expense. Receivables and payables are stated inclusive of the amount of GST receivable or payable. The net amount of GST recoverable from, or payable to, the taxation authority is included with other receivables or payables in the balance sheet.

Revenue Recognition

We recognize revenue from all sources based on the provisions of the U.S. SEC’s Staff Accounting Bulletin No. 104 and ASC 605 Revenue Recognition.

The Company’s revenue represents revenue from sales of products, provision of services and collaborative research and development agreements.

We recognize revenue from sales of products at the time title of goods passes to the buyer and the buyer assumes the risks and rewards of ownership, assuming all other revenue recognition criteria have been met. Generally, this is at the time products are shipped to the customer.

Revenue from services are recognized when a persuasive evidence of an arrangement exists, services have been rendered, the price is fixed or determinable, and collectability is reasonably assured. Revenue recognition principles are assessed for each new contractual arrangement and the appropriate accounting is determined for each service.

Where our agreements contain multiple elements, or deliverables, such as the manufacture and sale of products, provision of services or research and development activities, they are assessed to determine whether separate delivery of the individual elements of such arrangements comprises more than one unit of accounting. Where an arrangement can be divided into separate units of accounting (each unit constituting a separate earnings process), the arrangement consideration is allocated amongst those varying units based on the relative selling price of the separate units of accounting and the applicable revenue recognition criteria applied to the separate units. Selling prices are determined using fair value, either vendor specific objective evidence or third party evidence of the selling price, when available, or the Company’s best estimate of selling price when fair value is not available for a given unit of accounting.

Under ASC 605-25, which the Company adopted on January 1, 2009, the delivered item(s) are separate units of accounting, provided (i) the delivered item(s) have value to a customer on a stand-alone basis, and (ii) if the arrangement includes a general right of return relative to the delivered item, delivery or performance of the undelivered item(s) is considered probable and substantially in our control. Where the arrangement cannot be divided into separate units, the individual deliverables are combined as a single unit of accounting and the total arrangement consideration is recognized across other deliverables in the arrangement or over the estimated collaboration period. Payments under these arrangements typically include one or more of the following: non-refundable, upfront payments; funding of research and/or development efforts; and milestone payments.

We typically generate milestone payments from our customers pursuant to the various agreements we have with them. Non-refundable milestone payments which represent the achievement of a significant technical/regulatory hurdle in the research and development process, pursuant to collaborative agreements, and are deemed to be substantive, are recognized as revenue upon the achievement of the specified milestone If the non-refundable milestone payment is not substantive or stand-alone value, the non-refundable milestone payment is deferred and recognized as revenue either over the estimated performance period stipulated in the agreement or across other deliverables in the arrangement.

Management has concluded that the core operations of the Company are expected to be the research and development activities, commercial manufacture of approved medical or testing devices and the provision of services. The Company’s ultimate goal is to utilize the underlying technology and skill base for the development of a marketable product that the Company will manufacture. The Company considers revenue from the sales of products, revenue from services and the income received from milestone payments indicative of its core operating activities or revenue producing goals of the Company, and as such have accounted for this income as “revenues”.

Product and Service Agreements

In October 2007, the Company and LifeScan entered into a Master Services and Supply Agreement, under which the Company would provide certain services to LifeScan in the field of blood glucose monitoring and act as a non-exclusive manufacturer of blood glucose test strips. The Master Services and Supply Agreement was subsequently amended and restated in May 2009. The Company has concluded the Master Services and Supply Agreement should be accounted for as three separate units of accounting: 1) research and development to assist LifeScan in receiving regulatory clearance to sell the blood glucose product (milestone payment), 2) contract manufacturing of the blood glucose test strips (contract manufacturing) and 3) ongoing services and efforts to enhance the product (product enhancement).

All consideration within the Master Services and Supply agreement is contingent. The Company concluded the undelivered items were not priced at a significant incremental discount to the delivered items and revenue for each deliverable will be recognized as each contingency is met and the consideration becomes fixed and determinable. The milestone payment was considered to be a substantive payment and the entire amount has been recognized as revenue when the regulatory approval was received. Revenues for contract manufacturing and ongoing efforts to enhance the product are recognised as revenue from products or revenue from services, respectively, when the four basic criteria for revenue recognition are met.

In October 2011, the Company entered into a Statement of Work agreement with LifeScan to provide services for a feasibility study for an innovative blood glucose product. The services relating to this agreement are expected to take 12 months to complete which commenced in September 2011.

 

Research and Development Agreement

On September 9, 2011 the Company entered into a new collaboration agreement with Siemens to develop coagulation related products for hospital point-of-care and ambulatory care coagulation markets. In addition to an up-front, non-refundable payment of US$3 million; the Company may receive up to six payments from Siemens upon the achievement of certain defined milestones relating to feasibility, regulatory submissions and the launch of the products to be developed. The Company has concluded that the up-front payment is not a separate unit of accounting and recorded the amount as deferred revenue to be recognized as revenue across other deliverables in the arrangement with Siemens based upon the Company’s best estimate of selling price. The deliverables related to each milestone are considered substantive and are not priced at a significant incremental discount to the other deliverables. As the achievement of the milestones is contingent upon a future event, the revenue for each deliverable will be recognized as the contingencies are met and the consideration becomes fixed and determinable.

Interest income

Interest income is recognized as it accrues, taking into account the effective yield on the cash and cash equivalents.

Foreign Currency

Functional and reporting currency

Items included in the financial statements of each of the Group’s entities are measured using the currency of the primary economic environment in which the entity operates (“the functional currency”). The functional currency of the Company and UBS is AUD or A$ for all years presented.

The consolidated financial statements are presented using a reporting currency of Australian dollars.

Transactions and balances

Foreign currency transactions are translated into the functional currency using the exchange rates prevailing at the dates of the transactions. Foreign exchange gains and losses resulting from the settlement of such transactions and from the translation at year-end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognized in the consolidated statements of operations.

The Company has recorded foreign currency transaction losses of A$4,442, A$512,474 and A$250,886 in each of the years ended December 31, 2011, 2010 and 2009, respectively.

The results and financial position of all the Group entities that have a functional currency different from the reporting currency are translated into the reporting currency as follows:

 

  Ÿ  

assets and liabilities for each balance sheet item reported are translated at the closing rate at the date of that balance sheet;

 

  Ÿ  

income and expenses for each income statement are translated at average exchange rates (unless this is not a reasonable approximation of the effect of the rates prevailing on the transaction dates, in which case income and expenses are translated at the dates of the transactions); and

 

  Ÿ  

all resulting exchange differences are recognized as a separate component of equity.

On consolidation, exchange differences arising from the translation of any net investment in foreign entities are taken to the Accumulated Other Comprehensive Income.

Commitments and Contingencies

Liabilities for loss contingencies, arising from claims, assessments, litigation, fines, and penalties and other sources are recorded when it is probable that a liability has been incurred and the amount of the assessment can be reasonably estimated. These were nil as at December 31, 2011 (2010: nil).

 

Patent and License Costs

Legal fees incurred for patent application costs have been charged to expense and reported in research and development expense. Legal fees incurred for patents relating to commercialized products are capitalized and amortized over the life of the patents.

Clinical Trial Expenses

Clinical trial costs are a component of research and development expenses. These expenses include fees paid to participating hospitals and other service providers, which conduct certain testing activities on behalf of the Company. Depending on the timing of payments to the service providers and the level of service provided, the Company records prepaid or accrued expenses relating to these costs.

These prepaid or accrued expenses are based on estimates of the work performed under service agreements.

Leased Assets

All of the Company’s leases for the years ended December 31, 2011, 2010 and 2009 are considered operating leases. The costs of operating leases are charged to the statement of operations on a straight-line basis over the lease term.

Stock-based Compensation

We measure stock-based compensation at grant date, based on the estimated fair value of the award, and recognize the cost as an expense on a straight-line basis over the vesting period of the award. We estimate the fair value of stock options using the Trinomial Lattice model. We also grant our employees Restricted Stock Units (“RSUs”) and Zero Priced Employee Options (“ZEPOs”). RSUs are stock awards granted to employees that entitle the holder to shares of common stock as the award vests. ZEPOs are stock options granted to employees that entitle the holder to shares of common stock as the award vests. The value of RSUs and ZEPOs are determined and fixed on the grant date based on the Company’s stock price. See note 5 for further details.

We record deferred tax assets for awards that will result in deductions on our income tax returns, based on the amount of compensation cost recognized and our statutory tax rate in the jurisdiction in which we will receive a deduction. Differences between the deferred tax assets recognized for financial reporting purposes and the actual tax deduction reported in our income tax return are recorded in expense or in capital in excess of par value if the tax deduction exceeds the deferred tax assets or to the extent that previously recognized credits to paid-in-capital are still available if the tax deduction is less than the deferred tax asset.

Employee Benefit Costs

The Company contributes to standard defined contribution superannuation funds on behalf of all employees at nine percent of each such employee’s salary. Superannuation is a compulsory savings program whereby employers are required to pay a portion of an employee’s remuneration to an approved superannuation fund that the employee is typically not able to access until they are retired. The Company permits employees to choose an approved and registered superannuation fund into which the contributions are paid. Contributions are charged to the statement of operations as they become payable.

Net Profit/(Loss) per Share and Anti-dilutive Securities

Basic and diluted net profit/(loss) per share is presented in conformity with ASC 260 – Earnings per Share. Basic and diluted net profit/(loss) per share has been computed using the weighted-average number of common shares outstanding during the period. Other than in a profit making year, the potentially dilutive options issued under the Universal Biosensors Employee Option Plan were not considered in the computation of diluted net profit/(loss) per share because they would be anti-dilutive given the Company’s loss making position.

 

Total Comprehensive Income

The Company follows ASC 220 – Comprehensive Income. Comprehensive income is defined as the total change in shareholders’ equity during the period other than from transactions with shareholders, and for the Company, includes net income and cumulative translation adjustments.

Recent Accounting Pronouncements

In December 2011, the FASB issued ASU 2011-11 which amended the disclosure requirements regarding offsetting assets and liabilities of derivatives, sale and repurchase agreements, reverse sale and repurchase agreements, and securities borrowing and securities lending arrangements. The enhanced disclosures will require entities to provide both net and gross information for these assets and liabilities. The amendment is effective for fiscal years beginning on or after January 1, 2013. The Company does not anticipate that this amendment will have a material impact on its financial statements.

In June 2011, the FASB issued ASU No. 2011-05, Comprehensive Income (Topic 220): Presentation of Comprehensive Income. The new guidance allows an entity to present components of net income and other comprehensive income in one continuous statement, referred to as the statement of comprehensive income, or in two separate, but consecutive statements. The guidance eliminates the current option to report other comprehensive income and its components in the statement of changes in equity. While the new guidance changes the presentation of comprehensive income, there are no changes to the components that are recognized in net income or other comprehensive income under current accounting guidance. This new guidance is effective for fiscal years and interim periods beginning after December 15, 2011. This guidance will result in a change in the way we present Other Comprehensive Income and its components, but will not have an impact on our financial position, results of operations or cash flows.

In May 2011, the FASB issued ASU No. 2011-04, Fair Value Measurement (Topic 820): Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. generally accepted accounting principles (GAAP) and International Financial Reporting Standards (IFRS). This ASU is intended to result in convergence between U.S. GAAP and IFRS requirements for measurement of and disclosures about fair value. The guidance amends current fair value measurement and disclosure guidance to include increased transparency around valuation inputs and investment categorization. This new guidance is effective for fiscal years and interim periods beginning after December 15, 2011. We do not believe the adoption of the new guidance will have a significant impact on the company’s consolidated financial statements.

 

XML 20 R2.htm IDEA: XBRL DOCUMENT v2.4.0.6
Consolidated Condensed Balance Sheets (Unaudited) (AUD)
Dec. 31, 2011
Dec. 31, 2010
Current assets:    
Cash and cash equivalents 15,089,209 23,271,766
Inventories, net 3,619,400 3,191,093
Accounts receivable 4,889,783 3,588,798
Prepayments 92,048 303,181
Financial instruments 83,339 0
Other current assets 827,508 46,196
Total current assets 24,601,287 30,401,034
Non-current assets:    
Property, plant and equipment 33,151,027 32,713,280
Less accumulated depreciation (12,855,847) (9,586,365)
Property, plant and equipment - net 20,295,180 23,126,915
Other non-current assets 320,000 310,000
Total non-current assets 20,615,180 23,436,915
Total assets 45,216,467 53,837,949
Current liabilities:    
Accounts payable 620,682 1,764,364
Accrued expenses 2,061,528 2,099,477
Deferred revenue 3,509,721 0
Employee entitlements provision 824,833 596,294
Total current liabilities 7,016,764 4,460,135
Non-current liabilities:    
Asset retirement obligations 2,166,691 1,998,060
Employee entitlements provision 181,367 160,675
Deferred revenue 829,039 0
Total non-current liabilities 3,177,097 2,158,735
Total liabilities 10,193,861 6,618,870
Commitments and contingencies (Note 3)      
Stockholders' equity:    
Preferred stock, $0.01 par value. Authorized 1,000,000 shares; issued and outstanding nil in 2011 (2010: nil)      
Common stock, $0.0001 par value. Authorized 300,000,000 shares; issued and outstanding 159,139,965 shares in 2011 (2010: 158,871,495) 15,914 15,887
Additional paid-in capital 79,446,995 77,034,717
Accumulated deficit (29,533,213) (22,922,688)
Current year loss (14,692,117) (6,610,525)
Accumulated other comprehensive income (214,973) (298,312)
Total stockholders' equity 35,022,606 47,219,079
Total liabilities and stockholders' equity 45,216,467 53,837,949
XML 21 R6.htm IDEA: XBRL DOCUMENT v2.4.0.6
Consolidated Statements of Cash Flows (AUD)
12 Months Ended
Dec. 31, 2011
Dec. 31, 2010
Dec. 31, 2009
Cash flows from operating activities provided by/(used in):      
Net profit/(loss) (14,692,117) (6,610,525) 1,430,463
Adjustments to reconcile net profit/(loss) to net cash provided by/(used in) operating activities:      
Depreciation and amortization 3,298,541 2,990,858 2,851,285
Share based payments expense 2,255,842 1,677,003 1,078,771
Loss on fixed assets disposal 17,715 2,618 60,658
Change in assets and liabilities:      
Inventory (428,307) (2,885,969) (305,124)
Accounts receivables (1,300,985) (3,733,332) (114,713)
Prepaid expenses and other current assets (725,797) (6,079) 141,331
Deferred revenue 4,492,426 118,305 290,904
Employee entitlements 249,231 73,493 50,192
Accounts payable and accrued expenses (325,667) 1,959,380 383,389
Net cash provided by/(used in) operating activities (7,159,118) (6,414,248) 5,867,156
Cash flows from investing activities:      
Instalment payments to acquire plant and equipment   (988,334) (2,145,808)
Purchases of property, plant and equipment (1,102,943) (1,331,959) (844,199)
Net cash used in investing activities (1,102,943) (2,320,293) (2,990,007)
Cash flows from financing activities:      
Proceeds from borrowings     479,673
Repayment of borrowings     (479,673)
Proceeds from stock options exercised 79,504 715,296 78,998
Net cash provided by financing activities 79,504 715,296 78,998
Net increase/(decrease) in cash and cash equivalents (8,182,557) (8,019,245) 2,956,147
Cash and cash equivalent at beginning of period 23,271,766 31,291,011 28,334,864
Cash and cash equivalents at end of period 15,089,209 23,271,766 31,291,011
XML 22 R22.htm IDEA: XBRL DOCUMENT v2.4.0.6
Valuation and Qualifying Accounts
12 Months Ended
Dec. 31, 2011
Valuation and Qualifying Accounts [Abstract]  
Valuation and Qualifying Accounts Valuation and Qualifying Accounts

Universal Biosensors, Inc.

Schedule ii — Valuation and Qualifying Accounts

(for the years ended December 31, 2009, 2010 and 2011)

 

                                         
          Additions              
    Balance at
Beginning  of
Period
    Charged to
Costs  and
Expenses
    Charged to
Other
Accounts
    Deductions     Balance at
end of  Period
 
    A$     A$     A$     A$     A$  

Year ended December 31, 2009

                                       

Deferred income tax valuation allowance

    10,601,120       2,998,487             (1,899,796     11,699,811  

Year ended December 31, 2010

                                       

Deferred income tax valuation allowance

    11,699,811       1,896,668       372,305             13,968,784  

Year ended December 31, 2011

                                       

Deferred income tax valuation allowance

    13,968,784       4,357,503       30,161             18,356,448  
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Basis of Presentation
12 Months Ended
Dec. 31, 2011
Basis of Presentation [Abstract]  
Basis of Presentation
(1)  Basis of Presentation

These consolidated financial statements are presented in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). All amounts are expressed in Australian dollars (“AUD” or “A$”) unless otherwise stated.

The Company’s consolidated financial statements have been prepared assuming the Company will continue as a going concern. We rely largely on our existing cash and cash equivalents balance and operating cash flow to provide for the working capital needs of our operations. We believe we have sufficient cash and cash equivalents to fund our operations for at least the next twelve months. However, in the event, our financing needs for the foreseeable future are not able to be met by our existing cash and cash equivalents balance and operating cash flow, we would seek to raise funds through public or private equity offerings, debt financings, and through other means to meet the financing requirements. There is no assurance that funding would be available at acceptable terms, if at all.

During 2010, the Group (consisting of Universal Biosensors, Inc. and its wholly owned subsidiary, Universal Biosensors Pty Ltd) ceased to be a development stage enterprise as it has established its commercial scale manufacturing and is generating revenue from its manufacturing operations.

 

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Consolidated Condensed Balance Sheets (Parenthetical) (AUD)
Dec. 31, 2011
Dec. 31, 2010
Consolidated Condensed Balance Sheets [Abstract]    
Preferred stock, par value 0.01 0.01
Preferred stock, shares authorized 1,000,000 1,000,000
Preferred stock, shares issued      
Preferred stock, shares outstanding      
Common stock, par value 0.0001 0.0001
Common stock, shares authorized 300,000,000 300,000,000
Common stock, shares, issued 159,139,965 158,871,495
Common stock, shares, outstanding 159,139,965 158,871,495
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Retirement Benefits
12 Months Ended
Dec. 31, 2011
Retirement Benefits [Abstract]  
Retirement Benefits
(11)  Retirement Benefits

Universal Biosensors Pty Ltd contributes to standard defined contributions superannuation funds on behalf of all employees at an amount up to nine per cent of employee salary. The Company permits employees to choose the superannuation fund into which the contributions are paid, provided the fund is appropriately registered.

Universal Biosensors Pty Ltd contributed A$806,158, A$714,123 and A$698,919 for the fiscal years ended December 31, 2011, 2010 and 2009, respectively.

 

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Document and Entity Information
12 Months Ended
Dec. 31, 2011
Mar. 06, 2012
Jun. 30, 2011
USD ($)
Jun. 30, 2011
AUD
Document and Entity Information [Abstract]        
Entity Registrant Name UNIVERSAL BIOSENSORS INC      
Entity Central Index Key 0001279695      
Document Type 10-K      
Document Period End Date Dec. 31, 2011      
Amendment Flag false      
Document Fiscal Year Focus 2011      
Document Fiscal Period Focus FY      
Current Fiscal Year End Date --12-31      
Entity Well-known Seasoned Issuer No      
Entity Voluntary Filers No      
Entity Current Reporting Status Yes      
Entity Filer Category Accelerated Filer      
Entity Public Float     $ 91,993,437 85,662,946
Entity Common Stock, Shares Outstanding   159,146,213    
XML 29 R18.htm IDEA: XBRL DOCUMENT v2.4.0.6
Net Profit/(Loss) per Share
12 Months Ended
Dec. 31, 2011
Net Profit/(Loss) per Share [Abstract]  
Net Profit/(Loss) per Share
(12)  Net Profit/(Loss) per Share

Basic net profit/(loss) per ordinary share was computed by dividing the net profit/(loss) applicable to common stock by the weighted-average number of common stock outstanding during the period. Options granted to employees under the Universal Biosensors Employee Option Plan are considered to be potential ordinary shares for the purpose of calculating diluted net profit/(loss) per share. However, all these were not included in the calculation of diluted net profit/(loss) per share in the year when the Group made a net loss as the effect of including them is anti-dilutive.

 

                         
    Years Ended December 31,  
    2011     2010     2009  

Weighted average shares used as denominator in calculating:

                       

Basic net profit/(loss) per share

    159,017,777       157,584,044       157,013,578  
   

 

 

   

 

 

   

 

 

 

Diluted net profit/(loss) per share

    159,017,777       157,584,044       161,354,802  
   

 

 

   

 

 

   

 

 

 

 

XML 30 R4.htm IDEA: XBRL DOCUMENT v2.4.0.6
Consolidated Statements of Operations (AUD)
12 Months Ended
Dec. 31, 2011
Dec. 31, 2010
Dec. 31, 2009
Revenue      
Revenue from products 12,063,582 11,760,009 132,733
Revenue from services 2,632,870 6,420,027 2,850,071
Research and development income     1,337,125
Milestone payment     17,722,641
Total revenue 14,696,452 18,180,036 22,042,570
Operating costs & expenses      
Cost of goods sold 12,310,302 10,801,062 458,162
Cost of services 708,149 1,481,674 169,241
Research and development 9,812,396 6,482,150 14,898,072
General and administrative 7,271,488 7,185,550 5,635,569
Total operating costs & expenses 30,102,335 25,950,436 21,161,044
Profit/(loss) from operations (15,405,883) (7,770,400) 881,526
Other income/(expense)      
Interest income 683,323 1,192,889 809,459
Interest expense     (9,636)
Other 30,443 (33,014) (250,886)
Total other income/(expense) 713,766 1,159,875 548,937
Net profit/(loss) before tax (14,692,117) (6,610,525) 1,430,463
Income tax benefit/(expense) 0    
Net profit/(loss) (14,692,117) (6,610,525) 1,430,463
Basic net profit/(loss) per share (0.09) (0.04) 0.01
Average weighted number of shares - basic 159,017,777 157,584,044 157,013,578
Diluted net profit/(loss) per share (0.09) (0.04) 0.01
Average weighted number of shares - diluted 159,017,777 157,584,044 161,354,802
XML 31 R12.htm IDEA: XBRL DOCUMENT v2.4.0.6
Related Party Transactions
12 Months Ended
Dec. 31, 2011
Related Party Transactions [Abstract]  
Related Party Transactions
(6)  Related Party Transactions

Details of related party transactions material to the operations of the Group other than compensation arrangements, expense allowances, and other similar items in the ordinary course of business, are set out below:

In September 2011, we entered into a license agreement with SpeeDx Pty Ltd (“SpeeDx”) pursuant to which SpeeDx granted us a license in the field of molecular diagnostics. Under the agreement we make milestone payments totaling A$500,000 if certain specified targets are achieved and payments ranging from 5% to 15% of our sales and licensing revenues to SpeeDx. Messrs Denver and Jane are directors of the Company and SpeeDx Pty Ltd. Certain of our substantial shareholders also hold substantial shareholdings in SpeeDx. CM Capital Pty Ltd, which holds approximately 11% of our shares and of which Mr Jane is a director, holds approximately 34% of the issued shares in SpeeDx. PFM Cornerstone Limited, which holds approximately 8% of our shares and of which Messrs Denver and Hanley and Dr Adam are directors, holds approximately 34% of the issued shares in SpeeDx. Johnson & Johnson Development Corporation has a beneficial interest in approximately 9% of our shares. An affiliate of Johnson & Johnson, Johnson and Johnson Research Pty Ltd owns approximately 13% of issued shares in SpeeDx.

Based on the latest Amendment to Schedule 13G filed on January 25, 2012, Johnson and Johnson Development Corporation (a venture capital wholly owned subsidiary of Johnson & Johnson) beneficially held 14,915,400 shares in the Company as at December 31, 2011 which represents approximately 9.4% of the Company’s shares.

The following transactions occurred with LifeScan:

 

                         
    As of December, 31  
    2011     2010     2009  
    A$     A$     A$  

Current Receivables — Owing by LifeScan

                       

Sale of goods

    1,999,764       3,588,798          

Sale of services

    2,890,019                
   

 

 

   

 

 

         
      4,889,783       3,588,798          
   

 

 

   

 

 

         

Current Liabilities — Owing to LifeScan

                       

Purchase of goods

    786,708                
   

 

 

   

 

 

         

Revenue from LifeScan

                       

Revenue from products

    12,063,582       11,760,009       132,733  

Revenue from services

    2,632,870       6,420,027       2,850,071  

Research and develoment income

                1,337,125  

Milestone payment

                17,722,641  
   

 

 

   

 

 

   

 

 

 
      14,696,452       18,180,036       22,042,570  
   

 

 

   

 

 

   

 

 

 

 

XML 32 R11.htm IDEA: XBRL DOCUMENT v2.4.0.6
Employee Incentive Schemes
12 Months Ended
Dec. 31, 2011
Employee Incentive Schemes [Abstract]  
Employee Incentive Schemes
(5)  Employee Incentive Schemes

(a)  Stock Option Plan

In 2004, the Company adopted an employee option plan (“Plan”). Options may be granted pursuant to the Plan to any person considered by the board to be employed by the Group on a permanent basis (whether full time, part time or on a long term casual basis). Each option gives the holder the right to subscribe for one share of common stock. The total number of options that may be issued under the Plan is such maximum amount permitted by law and the Listing Rules of the Australian Securities Exchange (“ASX”). The exercise price and any exercise conditions are determined by the board at the time of grant of the options. Any exercise conditions must be satisfied before the options vest and become capable of exercise. The options lapse on such date determined by the board at the time of grant or earlier in accordance with the Plan. Options granted to date have had a term up to 10 years and generally vest in equal tranches over three years.

An option holder is not permitted to participate in a bonus issue or new issue of securities in respect of an option held prior to the issue of shares to the option holder pursuant to the exercise of an option. If Universal Biosensors changes the number of issued shares through or as a result of any consolidation, subdivision, or similar reconstruction of the issued capital of the Company, the total number of options and the exercise price of the options (as applicable) will likewise be adjusted. Options granted in 2009, 2010 and 2011 were 4,164,200, 914,500 and 3,555,500 respectively.

In accordance with ASC 718, the fair value of the option grants was estimated on the date of each grant using the Trinomial Lattice model. The assumptions for these grants were:

 

                                                                                                         
    Grant Date  
    Nov-11     Nov-11     Sep-11     Mar-11     Feb-11     Nov-10     Nov-10     Feb-10     Nov-09     Jun-09     Jun-09     May-09     Feb-09  

Exercise Price (A$)

    Nil       0.89       1.00       1.37       1.38       Nil       1.58       1.6       1.72       Nil       0.94       Nil       0.5  

Share Price at Grant Date (A$)

    0.89       0.89       1.00       1.37       1.38       1.58       1.58       1.6       1.73       0.95       0.95       1.18       0.43  

Volatility

    68     68     69     70     71     72     72     77     78     80     80     81     77

Expected Life (years)

    7       7       7       7       7       7       7       7       10       10       10       10       10  

Risk Free Interest Rate

    3.72     3.72     3.89     5.36     5.45     5.27     5.27     5.34     5.63     5.49     5.49     4.87     4.26

Fair Value of Option (A$)

    0.89       0.52       0.59       0.83       0.83       1.58       0.96       0.99       1.13       0.95       0.62       1.04       0.28  

Each of the inputs to the Trinomial Lattice model is discussed below.

Share price at valuation date

The value of the options granted in 2010 and 2011 has been determined using the closing price of our common stock trading in the form of CDIs on ASX at the time of grant of the options. The value of the options granted in 2009 have been determined using the average closing price of the Company’s common stock on the ASX on the five days on which the Company’s common stock has traded prior to the approval of grant. The ASX is the only exchange upon which our securities are quoted.

Volatility

We applied volatility having regard to the historical price change of our shares in the form of CDIs available from the ASX.

Time to Expiry

All options granted under our share option plan have a maximum 10 year term and are non-transferable.

Risk free rate

The risk free rate which we applied is equivalent to the yield on an Australian government bond with a time to expiry approximately equal to the expected time to expiry on the options being valued.

 

Stock option activity during the current period is as follows:

 

                 
    Number of
shares
    Weighted
average
exercise price
 
          A$  

Balance at December 31, 2010

    8,539,704       0.93  
   

 

 

   

 

 

 

Granted

    3,355,500       1.25  

Exercised

    (181,999     0.46  

Lapsed

    (295,669     1.33  
   

 

 

   

 

 

 

Balance at December 31, 2011

    11,417,536       1.02  
   

 

 

   

 

 

 

At December 31, 2011, the number of options exercisable was 8,011,691 (2010: 5,908,214 and 2009: 5,808,324). At December 31, 2011, total stock compensation expense recognized in income statement was A$2,255,842 (2010: A$1,677,003 and 2009: A$1,078,771).

The following table represents information relating to stock options outstanding under the plans as of December 31, 2011:

 

                         
    Options Outstanding        

Exercise Price

  Shares     Weighted
average
remaining
life in years
    Options
Exercisable
Shares
 
        A$                  

$0.30

    1,516,770       2.00       1,516,770  

$0.35

    443,099       4.00       443,099  

$1.18

    623,000       5.20       623,000  

$1.20

    590,000       5.70       590,000  

$1.13

                 

$0.89

    824,000       6.20       824,000  

$0.70

    224,667       6.60       224,667  

$0.50

    81,333       7.10       81,333  

Nil

    58,334       7.40       58,334  

$0.94

    1,201,000       7.50       1,201,000  

Nil

    410,000       7.50       116,663  

$1.72

    1,568,333       7.90       1,053,345  

$1.60

    50,000       5.10       33,332  

$1.58

    383,500       5.90       127,819  

Nil

    100,000       5.90       33,333  

$1.37

    355,000       6.20       118,330  

$1.38

    2,300,000       6.10       966,666  

$1.00

    86,000       6.70        

$0.89

    502,500       6.90        

Nil

    100,000       6.90        
   

 

 

           

 

 

 
      11,417,536               8,011,691  
   

 

 

           

 

 

 

 

The table below sets forth the number of employee stock options exercised and the number of shares issued in the period from December 31, 2009. We issued these shares in reliance upon exemptions from registration under Regulation S under the Securities Act of 1933, as amended.

 

                         

Period Ending

  Number of  Options
Exercised  and
Corresponding
Number of  Shares
Issued
    Weighted Average
Exercise Price
    Proceeds
Received
 
          A$     A$  

2009

    138,327       0.60       78,998  

2010

    1,667,581       0.49       715,296  

2011

    181,999       0.46       79,504  
   

 

 

           

 

 

 

Total

    1,987,907               873,798  
   

 

 

           

 

 

 

As of December 31, 2011, there was A$1,673,079 of unrecognized compensation expense related to unvested share-based compensation arrangements under the Employee Option Plan. This expense is expected to be recognized as follows:

 

         

Fiscal Year

  A$  

2012

    1,208,797  

2013

    412,575  

2014

    51,707  
   

 

 

 
      1,673,079  
   

 

 

 

The aggregate intrinsic value for all options outstanding as at December 31, 2011 was zero.

(b)  Restricted Share Plan

Our Employee Share Plan was adopted by the Board of Directors in 2009. The Employee Share Plan permits our Board to grant shares of our common stock to our employees and directors. The number of shares able to be granted is limited to the amount permitted to be granted at law, the ASX Listing Rules and by the limits on our authorized share capital in our certificate of incorporation. All our employees are eligible for shares under the Employee Plan. The Company currently proposes to continue to issue A$1,000 worth of restricted shares of common stock to employees of the Company on a recurring basis, but no more frequently than annually. The restricted shares have the same terms of issue as our existing shares of common stock but are not able to be traded until the earlier of three years from the date on which the shares are issued or the date the relevant employee ceases to be an employee of the Company or any of its associated group of companies.

The table below sets forth the restricted shares issued by the Company:

 

                 
    Number of
Restricted
Shares Issued
    Market
Value of
Restricted
Shares Issued
 

November, 2009

    40,670     A$ 69,952  

May, 2010

    581     A$ 999  

November, 2010

    47,400     A$ 74,892  

November, 2011

    86,471     A$ 76,959  

 

Restricted stock awards activity during the current period is as follows:

 

                 
    Number of
shares
    Weighted
average
issue price
 
          A$  

Balance at December 31, 2010

    82,841       1.64  
   

 

 

   

 

 

 

Granted

    86,471       0.89  

Release of restricted shares

    (11,549     1.64  
   

 

 

   

 

 

 

Balance at December 31, 2011

    157,763       1.23  
   

 

 

   

 

 

 

 

XML 33 R19.htm IDEA: XBRL DOCUMENT v2.4.0.6
Guarantees and Indemnifications
12 Months Ended
Dec. 31, 2011
Guarantees and Indemnifications [Abstract]  
Guarantees and Indemnifications
(13) Guarantees and Indemnifications

The certificate of incorporation and amended and restated by-laws of the Company provide that the Company will indemnify officers and directors and former officers and directors in certain circumstances, including for expenses, judgments, fines and settlement amounts incurred by them in connection with their services as an officer or director of the Company or its subsidiaries, provided that such person acted in good faith and in a manner such person reasonably believed to be in the best interests of the Company.

 

In addition to the indemnities provided in the certificate of incorporation and amended and restated by-laws, the Company has entered into indemnification agreements with certain of its officers and each of its directors. Subject to the relevant limitations imposed by applicable law, the indemnification agreements, among other things:

 

  Ÿ  

indemnify the relevant officers and directors for certain expenses, judgments, fines and settlement amounts incurred by them in connection with their services as an officer or director of the Company or its subsidiaries; and

 

  Ÿ  

require the Company to make a good faith determination whether or not it is practicable to maintain liability insurance for officers and directors or to ensure the Company’s performance of its indemnification obligations under the agreements.

The Company maintains directors’ and officers’ liability insurance providing for the indemnification of our directors and certain of our officers against certain liabilities incurred as a director or officer, including costs and expenses associated in defending legal proceedings. In accordance with the terms of the insurance policy and commercial practice, the amount of the premium is not disclosed.

No liability has arisen under these indemnities as at December 31, 2011.

 

XML 34 R15.htm IDEA: XBRL DOCUMENT v2.4.0.6
Accrued Expenses
12 Months Ended
Dec. 31, 2011
Accrued Expenses [Abstract]  
Accrued Expenses
(9)  Accrued Expenses

Accrued expenses consist of the following:

 

                 
    As of December, 31  
    2011     2010  
    A$     A$  

Legal, tax and accounting fees

    511,121       591,184  

Salary and related costs

    706,053       587,695  

Research and development materials

    35,050       120,000  

Production materials

    786,708       657,142  

Other

    22,596       143,456  
   

 

 

   

 

 

 
      2,061,528       2,099,477  
   

 

 

   

 

 

 

 

XML 35 R13.htm IDEA: XBRL DOCUMENT v2.4.0.6
Financial Instruments
12 Months Ended
Dec. 31, 2011
Financial Instruments [Abstract]  
Financial Instruments
(7)  Financial Instruments

Financial Assets

 

                         
    Years Ended December 31,  
    2011     2010     2009  
    A$     A$     A$  

Financial assets:

                       

Cash and cash equivalents

    15,089,209       23,271,766       31,291,011  

Accounts receivables

    4,889,783       3,588,798       415,397  

Financial instruments

    83,339              
   

 

 

   

 

 

   

 

 

 

Total financial assets

    20,062,331       26,860,564       31,706,408  
   

 

 

   

 

 

   

 

 

 

Debt:

                       

Short and long term debt/borrowings

                 

Financial instruments

                47,412  
   

 

 

   

 

 

   

 

 

 

Total debt

                47,412  
   

 

 

   

 

 

   

 

 

 

Net financial assets

    20,062,331       26,860,564       31,658,996  
   

 

 

   

 

 

   

 

 

 

The carrying value of the cash and cash equivalents and the accounts receivables approximates fair value because of their short-term nature.

We regularly review all our financial assets for impairment. There were no impairments recognized in 2011, 2010 and 2009.

Derivative Instruments and Hedging Activities

In determining fair value, we utilize valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible as well as consider our own and counterparty credit risk. At December 31, 2011 and 2010 we did not have any assets or liabilities that utilize Level 3 inputs. The valuation of our foreign exchange derivatives are based on the market approach using observable market inputs, such as forward rates and incorporate non-performance risk (the credit standing of the counterparty when the derivative is in a net asset position, and the credit standing of the Company when the derivative is in a net liability position). Our derivative assets are categorized as Level 2.

At December 31, 2011 (2010: nil) we had outstanding contracts with a notional amount of US$4.0 million. The fair value of these contracts at December 31, 2011 (2010: nil) was an asset of A$83,339 recorded as ‘Financial Instruments’ in consolidated balance sheet. As of December 31, 2011, substantially all of the derivative gain recognized in accumulated other comprehensive income (AOCI) will be recognized in earnings within the next 12 months. No amount of ineffectiveness was recorded in earnings for these designated cash flow hedges for the year ended December 31, 2011 (2010: nil). For further details, see Notes to Consolidated Financial Statements — Note 2. Summary of Significant Accounting Policies.

 

XML 36 R14.htm IDEA: XBRL DOCUMENT v2.4.0.6
Property, Plant and Equipment
12 Months Ended
Dec. 31, 2011
Property, Plant and Equipment [Abstract]  
Property, Plant and Equipment
(8)  Property, Plant and Equipment

 

                 
    As of December, 31  
    2011     2010  
    A$     A$  

Plant and equipment

    18,893,890       15,110,554  

Leasehold improvements

    8,722,639       8,810,036  

Capital work in process

    5,534,498       8,792,690  
   

 

 

   

 

 

 
      33,151,027       32,713,280  

Accumulated depreciation

    (12,855,847     (9,586,365
   

 

 

   

 

 

 

Property, plant & equipment, net

    20,295,180       23,126,915  
   

 

 

   

 

 

 

Capital work in process relates to assets under construction and comprises primarily of specialized manufacturing equipment. Legal right to the assets under construction rests with the Company. The amounts capitalized for capital work in process represents the percentage of expenditure that has been completed, and once the assets are placed into service the Company begins depreciating the respective assets. The accumulated amortisation of capitalised leasehold improvements for the fiscal years ended December 31, 2011, 2010 and 2009 was A$5,376,432, A$4,090,724 and A$2,770,434, respectively.

The Company receives Victorian government grants under certain research agreements to purchase plant and equipment. Plant and equipment is presented net of the government grant of A$680,221 for the year ended December 31, 2011 (2010: A$449,875). The grants are recognized against the acquisition costs of the related plant and equipment as and when the related assets are purchased. Grants received in advance of the relevant expenditure are treated as deferred income and included in Current Liabilities on the balance sheet as the Company does not control the monies until the relevant expenditure has been incurred. Grants due to the Company under research agreements are recorded as Currents Assets on the consolidated balance sheets.

Depreciation expense was A$3,298,541, A$2,990,858 and A$2,851,285 for the fiscal years ended December 31, 2011, 2010 and 2009, respectively.

 

XML 37 R16.htm IDEA: XBRL DOCUMENT v2.4.0.6
Stockholders' Equity - Common Stock
12 Months Ended
Dec. 31, 2011
Stockholders' Equity - Common Stock [Abstract]  
Stockholders' Equity - Common Stock
(10)  Stockholders’ Equity — Common Stock

Holders of common stock are generally entitled to one vote per share held on all matters submitted to a vote of the holders of common stock. At any meeting of the shareholders, the presence, in person or by proxy, of the majority of the outstanding stock entitled to vote shall constitute a quorum. Except where a greater percentage is required by the Company’s Amended and Restated Certificate of Incorporation or By-laws, the affirmative vote of the holders of a majority of the shares of common stock then represented at the meeting and entitled to vote at the meeting shall be sufficient to pass a resolution. Holders of common stock are not entitled to cumulative voting rights with respect to the election of directors, and the common stock does not have pre-emptive rights.

Trading in our shares of common stock on ASX is undertaken using CHESS Depositary Interests (“CDIs”). Each CDI represents beneficial ownership in one underlying share. Legal title to the shares underlying CDIs is held by CHESS Depositary Nominees Pty Ltd (“CDN”), a wholly owned subsidiary of ASX.

Holders of CDIs have the same economic benefits of holding the shares, such as dividends (if any), bonus issues or rights issues as though they were holders of the legal title. Holders of CDIs are not permitted to vote but are entitled to direct CDN how to vote. Subject to Delaware General Corporation Law, dividends may be declared by the Board and holders of common stock may be entitled to participate in such dividends from time to time.

 

XML 38 R21.htm IDEA: XBRL DOCUMENT v2.4.0.6
Deed of Cross Guarantee
12 Months Ended
Dec. 31, 2011
Deed of Cross Guarantee [Abstract]  
Deed of Cross Guarantee
(15)  Deed of Cross Guarantee

Universal Biosensors, Inc. and its wholly owned subsidiary, Universal Biosensors Pty Ltd, are parties to a deed of cross guarantee under which each company guarantees the debts of the other. By entering into the deed, the wholly-owned entity has been relieved from the requirements to prepare a financial report and directors’ report under Class Order 98/1418 (as amended) issued by the Australian Securities and Investments Commission.

The above companies represent a “Closed Group” for the purposes of the Class Order, and as there are no other parties to the Deed of Cross Guarantee that are controlled by Universal Biosensors, Inc., they also represent the “Extended Closed Group”.

The consolidated financial statements presented within this report comprise that of Universal Biosensors, Inc. and its wholly owned subsidiary, Universal Biosensors Pty Ltd. These two entities also represent the “Closed Group” and the “Extended Closed Group”.

XML 39 R5.htm IDEA: XBRL DOCUMENT v2.4.0.6
Consolidated Statement of Changes in Stockholders' Equity and Comprehensive Income (AUD)
Total
Ordinary Shares
Additional Paid-in Capital
Accumulated Deficit
Other Comprehensive Income
Beginning Balance at Dec. 31, 2008 48,703,230 15,698 73,338,995 (24,353,151) (298,312)
Beginning Balance, shares at Dec. 31, 2008   156,976,936      
Comprehensive income          
Unrealized gain (loss) on derivatives and hedges (47,412)       (47,412)
Net profit/(loss) 1,430,463     1,430,463  
Total Comprehensive income 1,383,051        
Exercise of stock options issued to employees, shares   138,327      
Exercise of stock options issued to employees 78,998 14 78,984    
Shares issued to employees, shares   40,670      
Shares issued to employees 69,952 4 69,948    
Stock option expense 1,078,771   1,078,771    
Ending Balance at Dec. 31, 2009 51,314,002 15,716 74,566,698 (22,922,688) (345,724)
Ending Balance, shares at Dec. 31, 2009   157,155,933      
Comprehensive income          
Unrealized gain (loss) on derivatives and hedges 47,412       47,412
Net profit/(loss) (6,610,525)     (6,610,525)  
Total Comprehensive income (6,563,113)        
Exercise of stock options issued to employees, shares   1,667,581      
Exercise of stock options issued to employees 715,296 167 715,129    
Shares issued to employees, shares   47,981      
Shares issued to employees 75,891 4 75,887    
Stock option expense 1,677,003   1,677,003    
Ending Balance at Dec. 31, 2010 47,219,079 15,887 77,034,717 (29,533,213) (298,312)
Ending Balance, shares at Dec. 31, 2010   158,871,495      
Comprehensive income          
Unrealized gain (loss) on derivatives and hedges 83,339       83,339
Net profit/(loss) (14,692,117)     (14,692,117)  
Total Comprehensive income (14,608,778)        
Exercise of stock options issued to employees, shares   181,999      
Exercise of stock options issued to employees 79,504 18 79,486    
Shares issued to employees, shares   86,471      
Shares issued to employees 76,959 9 76,950    
Stock option expense 2,255,842   2,255,842    
Ending Balance at Dec. 31, 2011 35,022,606 15,914 79,446,995 (44,225,330) (214,973)
Ending Balance, shares at Dec. 31, 2011   159,139,965      
XML 40 R10.htm IDEA: XBRL DOCUMENT v2.4.0.6
Income Taxes
12 Months Ended
Dec. 31, 2011
Income Taxes [Abstract]  
Income Taxes
(4)  Income Taxes

The Company is subject to income tax in Australia and is required to pay taxes on its Australian profits. As provided under the Australian income tax laws, the Company and its wholly owned resident subsidiary have formed a tax-consolidated group. Universal Biosensors, Inc. is required to lodge U.S. federal income tax returns. It currently is in a tax loss situation.

 

A reconciliation of the (benefit)/provision for income taxes with the amount computed by applying the Australian statutory company tax rate of 30% to the profit/(loss) before income taxes is as follows:

 

                                                 
    Years ended December 31,  
    2011     2010     2009  
    A$     %     A$     %     A$     %  

Profit/(loss) before income taxes

    (14,692,117             (6,610,525             1,430,463          

Computed by applying income tax rate of home jurisdiction

    (4,407,635     30       (1,983,157     30       429,139       30  

Research & development incentive

    (635,470     4       (421,341     6       (3,524,333     (246

Disallowed expenses/(income):

                                               

Share based payment

    676,753       (4     503,100       (7     323,631       22  

Other

    8,849             4,730             (226,924     (16

Change in valuation allowance

    4,357,503       (30     1,896,668       (29     2,998,487       210  
   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Income tax expense/(benefit)

                                   
   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Significant components of the Company’s deferred tax assets are shown below:

 

                 
    As of December 31,  
    2011 A$     2010 A$  

Deferred tax assets:

               

Operating loss carry forwards

    16,794,322       12,923,654  

Unamortized capital raising cost

    1,000       104,850  

Depreciation and amortization

    (378,385     (663,990

Asset retirement obligations

    650,007       599,418  

Employee entitlements

    301,860       227,090  

Other

    987,644       807,923  
   

 

 

   

 

 

 

Total deferred tax assets

    18,356,448       13,998,945  

Valuation allowance for deferred tax assets

    (18,356,448     (13,998,945
   

 

 

   

 

 

 

Net deferred tax asset

           
   

 

 

   

 

 

 

Significant components of deferred income taxes reflect the net tax effect of temporary differences between the carrying amounts of assets and liabilities for financial reporting and tax purposes. A valuation allowance has been established, as realization of such assets is not more likely than not.

At December 31, 2011 the Company has A$55,981,074 (A$43,078,848 at December 31, 2010) of accumulated tax losses available for carry forward against future earnings, which under Australian tax laws do not expire but may not be available under certain circumstances.

 

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Segments
12 Months Ended
Dec. 31, 2011
Segments [Abstract]  
Segments
(14)  Segments  

The Company operates in one segment. The principal activities of the Company are research and development, commercial manufacture of approved medical or testing devices and the provision of services including contract research work.

The Company operates predominantly in one geographical area, being Australia.